Abstract
Background
Acute kidney injury (AKI) worsens outcomes in low- and middle-income countries, largely due to delayed diagnosis and limited access to renal replacement therapy. Its true epidemiology remains unclear, partly due to delayed biochemical testing. In a prior phase of our work, we evaluated point-of-care creatinine (POC Cr) technology and its use in implementing a clinical algorithm to select patients at risk of AKI in a Nigerian hospital emergency department. In this study, POC Cr was used in a large primary care health center in Nigeria.
Methods
The study was conducted at Ozuoba Model Comprehensive Primary Health Care Centre in Nigeria, where renal function tests are rarely available and external laboratory results typically take over 48 h. POC Cr testing was introduced for high-risk adults using the clinical algorithm developed in the previous phase of this programme and for children with suspected severe illness based on clinical judgement or reduced urine output. Adjusted POC Cr values were calculated (POC Cr – 27.2 µmol/L), and AKI was staged using KDIGO criteria, with baseline creatinine defined as 100 µmol/L for adults and age-specific norms for children.
Results
A total of 424 patients were tested using POC Cr, comprising 301 adults and 123 children. Malaria was the most frequent diagnosis, accounting for 293 cases (61.1%). The median adjusted POC Cr across the entire cohort was 72.8 µmol/L (interquartile range [IQR]: 36). Among adult patients, AKI was diagnosed in 2 out of the 301 individuals (0.6%), one stage 1 and one stage 2, both of whom had malaria. In the paediatric group, the median age was 5 years (IQR: 7), with females comprising 65% of the cohort. Malaria was diagnosed in 69.9% of the children. AKI was identified in 70 out of 123 children (56.9%), with AKI stage 1 in 25 (20.3%), stage 2 in 26 (21.2%), and stage 3 in 19 children (15.4%). Among the 70 paediatric AKI cases, 49 (70%) had malaria. The highest prevalence of AKI was seen in children under 5 years of age, with the incidence declining steadily and reaching zero beyond age 12.
Conclusion
Our study found that more than half of paediatric patients diagnosed with malaria at a primary health care level had AKI, highlighting AKI as a common complication of malaria in young children. These findings emphasise the need for further research to support informed potential updates to WHO malaria treatment guidelines to incorporate the KDIGO definition of AKI, particularly in the context of paediatric care in low-resource settings.
Keywords: Malaria, Acute kidney injury, Point-of-care creatinine
Introduction
Acute kidney injury (AKI) remains a significant global health challenge, with persistently poor outcomes despite advances in understanding its pathophysiology [1, 2]. This burden is particularly pronounced in low- and middle-income countries [3], where delayed diagnosis and limited access to renal replacement therapy contribute to worse outcomes. In sub-Saharan Africa, even when blood samples are transported to centralised laboratories, processing often takes 48–72 hours – delaying diagnosis and limiting the integration of AKI detection into real-time clinical decision-making.
In Nigeria, as in many other developing countries, the majority of AKI cases are community-acquired, often linked to infections and obstetric complications. Affected individuals tend to be younger than those typically seen in high-income settings, and diagnosis is frequently delayed due to the lack of timely renal function testing. There is an urgent clinical need to develop systems that enable early AKI detection and intervention [3]. Point-of-care creatinine (POC Cr) technologies offer a promising solution, providing rapid results from minimal capillary or venous blood samples, and are well suited to resource-limited settings where access to central laboratories is restricted [4].
With support from the International Society of Nephrology (ISN), we previously conducted a collaborative project involving the Renal Unit of the University of Port Harcourt Teaching Hospital (UPTH), the Rivers State Primary Health Care Board, and the Renal Department of Salford Royal NHS Foundation Trust [5]. This initiative evaluated the performance of the StatSensor Xpress Creatinine device (Nova Biomedical Corporation, Waltham, MA, USA) using capillary samples, comparing results to concurrent venous samples analysed with the hospital’s standard laboratory assay (Jaffe method) in 96 adult outpatients undergoing routine blood testing at UPTH. The evaluation demonstrated a strong Pearson correlation (r = 0.956) and a Bland-Altman mean bias of 27.2 μmol/L [5].
Findings were presented at an AKI workshop attended by 85 clinicians from both primary and secondary care. Based on the workshop discussions, a clinical algorithm was developed for the use of POC Cr in AKI risk assessment, incorporating an adjustment in POC Cr results to account for device bias and imprecision. In the second phase of the project, this algorithm was implemented in the emergency department for adult patients with suspected community-acquired AKI, yielding an AKI detection rate of 36% [5]. In the current phase of the study, we extended the use of POC Cr to a large primary healthcare centre in Nigeria to further explore the burden and characteristics of community-acquired AKI in this setting.
Methods
Setting and Participants
The study was conducted at Ozuoba Model Comprehensive Primary Health Care Centre in Nigeria. Historically, decision-making is based largely on clinical judgement, and renal function tests when requested from external laboratories are typically reported after more than 48 h. The centre records approximately 4,150 patient attendances per month (60.8% paediatrics). During this project, POC Cr was offered to high-risk adult patients based on the clinical algorithm from the previous stage [5]. In view of the large paediatric population served by the centre, a decision was made jointly with the local stakeholders to expand the POC Cr screening to high-risk paediatric patients to estimate the burden of AKI in this population.
Participants
Adult Patients (≥16 Years Old)
In adult patients POC Cr testing was offered based on clinical observations or clinical history as outlined in Figure 1. In brief, patients with suspected infection or at risk of hypovolaemia and any of the following were considered high risk: respiratory rate >22/min, systolic blood pressure <100 mmHg, pulse rate >90 bpm, altered mental status or no urine output for >12 h. POC Cr was also offered in the presence of fluid retention, history of prolonged infection, history of nephrotoxins, animal venoms and known chronic kidney disease in the absence of abnormal clinical observations.
Fig. 1.
Algorithm for selection of high risk for AKI in adult patients.
Paediatric Patients (<16 Years of Age)
Paediatric patients were tested with POC Cr based on history suggesting diminished urine output or severity of clinical presentation as judged by the attending clinician.
Point-of-Care Testing
The POC Cr technology StatSensor Xpress Creatinine (Nova Biomedical Corporation, Waltham, MA, USA) was used. The StatSensor Xpress Creatinine analyser is a handheld device designed for the quantitative measurement of creatinine in capillary, venous, and arterial whole blood. Only capillary samples were used in this study. The instrument operates within a temperature range of 15–40°C and relative humidity of 10–90%.
The StatSensor Xpress employs an enzymatic method with amperometric detection of the generated hydrogen peroxide (H2O2) to determine creatinine levels. The required sample volume is 1.2 µL, and results are displayed within 30 s. Due to the small sample volumes used in capillary sampling, as well as variability related to sampling technique and puncture site, this method is susceptible to pre-analytical errors.
Previous studies have reported that the StatSensor Xpress Creatinine point-of-care technology overestimates creatinine levels by approximately 22–33% [6, 7]. In our own evaluation, comparing POC Cr measurements with the reference laboratory Jaffe assay at the affiliated hospital, we observed a mean positive bias of 27.2 µmol/L [5]. Consequently, all POC Cr values in this study were adjusted for this systematic bias using the following correction:
Adjusted POC Cr = POC Cr – 27.2.
Quality controls were conducted prior to data collection for the POC devices according to the manufacturer’s instructions. Malaria POC testing using lateral flow immunochromatography (STANDARD Q Malaria P.f/Pan Ag Test) to detect Plasmodium antigens in a finger-prick sample of blood was used.
AKI Definitions
As baseline creatinine values obtained within 3 months of presentation were unlikely to be available for the majority of participants, a pragmatic approach was adopted. A single creatinine measurement at presentation was used, and the baseline value was assumed based on the normal reference range to determine AKI stages.
AKI stages were calculated based on Kidney Disease: Improving Global Outcomes (KDIGO) criteria [8] using as baseline reference creatinine the upper limit of normal range (100 umol/L in adults) and upper limit of normal range based on age category for paediatric patients [9] (Fig. 2). There was no adjustment for sex in adult patients and no adjustment for height in paediatric patients.
Fig. 2.
Normal creatinine values in paediatric patients. Adjusted from “Guidance for clinicians managing children at risk of, or with, acute kidney injury,” Think Kidneys NHS, revised December 2019, original publication date May 2016, accessed online at AKI-Guidance-paediatric-patients-Dec2019.pdf.
AKI stage 1 was defined as an adjusted POC Cr level that is 1.5–2 times the baseline reference creatinine. AKI stage 2 was defined as 2–3 times the baseline reference and AKI stage 3 as greater than 3 times the baseline reference creatinine.
Statistical Analysis
In the descriptive analysis, continuous variables were expressed as median and interquartile range (IQR; Q3–Q1), and categorical variables were expressed as numbers and percentages. Analysis was conducted using SPSS version 26 licenced to the University of Manchester.
Results
In total, 424 patients, 301 adults and 123 paediatric patients, underwent POC Cr testing. Median adjusted POC Cr for the total population was 72.8 umol/L, with an IQR of 36.
Adult Patients (≥16 Years of Age)
In total, 301 adult patients were screened with POC Cr; median age was 43 (IQR 81), and 188 (62.5%) were females. The median adjusted POC Cr was 72.8 umol/L (IQR 35), and 188 (62.5%) were diagnosed with malaria. The clinical diagnosis of patients is presented in Table 1. Recording of vital signs on presentation was incomplete for most patients, and only 23.6% of patients met the clinical observation algorithm criteria for testing with POC Cr based on blood pressure, respiratory rate, and pulse rate (Table 1). Information on mental status and reduced urine output was only occasionally recorded and is not included in the analysis. There were 2 cases of AKI (0.6%) (one stage 1 and one stage 2), and both patients were diagnosed with malaria and were treated with oral antimalarial treatment.
Table 1.
Clinical characteristics of patients screened with POC Cr aged above 16 years of age
| Age, median (IQR) | 43 (29) |
| Sex (female), n (%) | 188 (62.5) |
| Confirmed malaria, n (%) | 205 (68.1) |
| Other diagnosis, n (%) | Acute gastroenteritis: 26 (8.6) |
| Urinary tract infection: 17 (5.6) | |
| Suspected appendicitis: 14 (4.6) | |
| Respiratory tract infection: 12 (3.9) | |
| Peptic ulcer disease: 9 (2.9) | |
| Other: 16 (5.3) | |
| Systolic BP recorded (patients), n (%) | 237 (78.7) |
| Systolic BP, mmHg, median (IQR) | 1,114.5 (31) |
| RR recorded (patients), n (%) | 78 (25.9) |
| RR, per minute, median (IQR) | 17 (6) |
| PR recorded (patients), n (%) | 126 (41.8) |
| PR, per minute, median (IQR) | 88 (12) |
| Patients meeting at least one clinical observation criterion for BP, RR, and PR | 73 (23.6) |
| POC Cr (adjusted), μmol/L, median (IQR) | 72.8 (35) |
| AKI, n (%) | 2 (0.66) |
Continuous variables are expressed as median (IQR). Categorical variables are presented as numbers (percentage).
AKI, acute kidney injury; BP, blood pressure; PR, pulse rate; RR, respiratory rate.
Paediatric Patients (<16 Years of Age)
There were 123 paediatric patients screened with POC Cr, median age 5 (IQR 14.9), 65% females, and 69.9% were diagnosed with malaria. The median POC Cr was 73.8 μmol/L (IQR 46.5). There were 70 (56.9%) cases of AKI. AKI stage 1 was detected in 25 patients (20.3%), AKI stage 2 in 26 patients (21.2%) and AKI stage 3 in 19 patients (15.4%). Malaria was diagnosed in 49 out of 70 AKI cases (70%) (Table 2; Fig. 3). Clinical diagnosis of patients is presented in Table 2. The highest rates of AKI were observed in younger children, declining to zero after the age of 12 (Fig. 3).
Table 2.
Clinical characteristics of patients screened with POC Cr aged below 16 years of age
| Age | 5 (7) |
| Sex (female), n (%) | 80 (65) |
| Confirmed malaria, n (%) | 86 (69.9) |
| Other diagnosis, n (%) | Acute gastroenteritis: 14 (11.3) |
| Respiratory tract infection: 13 (10.5) | |
| Suspected appendicitis: 3 (2.4) | |
| Urinary tract infection: 2 (1.6) | |
| Other: 5 (4) | |
| POC Cr (adjusted), μmol/L, median (IQR) | 73.8 (46.5) |
| AKI, n (%) | Total: 70 (56.9) |
| AKI stage 1: 25 (20.3) | |
| AKI stage 2: 26 (21.2) | |
| AKI stage 3: 19 (15.4% | |
| AKI associated with malaria: 49 (70) | |
| Systolic blood pressure recorded (patients), n (%) | 0 |
| Respiratory rate recorded (patients), n (%) | 25 (20.3) |
| Respiratory rate, per minute, median (IQR) | 28 (27) |
| Pulse rate recorded (patients), n (%) | 38 (30.9) |
| Pulse rate, per minute, median (IQR) | 103 (8) |
Continuous variables are expressed as median (IQR). Categorical variables are presented as numbers (percentage).
AKI, acute kidney injury.
Fig. 3.
Paediatric cases by age group, AKI, and malaria diagnosis.
In total 9 patients with AKI under the age of 16 were admitted for intravenous therapy to the day case unit. Among those, there were 5 patients with malaria (3 patients with AKI stage 3, 1 patient with AKI stage 2, and 1 patient with AKI stage 1), 3 patients with gastroenteritis/enteric fever (1 patient with AKI stage 3 and 2 patients with AKI stage 2), and 1 patient with hypertension and AKI stage 2. None of the paediatric patients was referred to the regional hospital. Patients diagnosed with malaria were treated with oral, intramuscular, or intravenous antimalarial treatment based on severity of presentation and clinical judgement.
Only one adult, and none of the 70 children with AKI, had creatinine levels exceeding the WHO threshold of 265 μmol/L. A scatter diagram of adjusted POC Cr levels by age is presented in Figure 4.
Fig. 4.
Scatter diagram showing adjusted POC Cr levels by age.
Discussion
This study demonstrates that AKI is a frequent complication of malaria in young children presenting to a Primary Health Care Centre in Nigeria. These children were screened using POC Cr testing based on clinical judgement of disease severity. In contrast, the AKI detection rate among patients older than 16 years was low (0.6%), with clinical assessments often made without reliance on vital signs at presentation. Malaria was the most common presenting diagnosis in both adults and children and the leading cause of AKI.
Severe AKI is a common feature of severe malaria occurring in up to 45% of adult patients and is associated with increased mortality [10]. Suggested underlying mechanisms for kidney dysfunction in the context of malaria include direct renal damage from the parasites, secondary immune complex deposition and inflammation, systemic nephrotoxic manifestations of haemolysis and rhabdomyolysis, and loss of renal perfusion due to haemodynamic instability. AKI, based on the KDIGO definition [8], is present in 24–59% of paediatric severe malaria cases and is associated with increased mortality [11–13]. Our study included mostly non-severe malaria cases based on the WHO definition [14] as these patients would present directly to the hospital or would be transferred immediately to the hospital from the primary care centre. To our knowledge, this is the first study reporting a high prevalence of AKI among paediatric malaria patients at the primary care level.
Malaria remains a major global health challenge, with Africa accounting for 95% of the world’s malaria cases and 96% of the associated 627,000 deaths reported in 2020. Over two-thirds of these deaths occur in children under five in sub-Saharan Africa [15].
The WHO defines AKI in severe malaria based on serum creatinine levels exceeding 3 mg/dL (>265 μmol/L) or urea levels above 120 mg/dL (>20 mmol/L) [14]. While these thresholds identify severe cases in adults, they are not suitable for children, whose normal creatinine levels vary significantly with age, size, and gender. For instance, a 3-year-old child with a creatinine level of 100 μmol/L would meet criteria for stage 3 AKI, despite this value being within the normal adult range. This discrepancy is critical, especially since children under five bear the highest malaria mortality burden [15]. Detection of AKI in children could allow for timely interventions during the early stages, potentially improving outcomes and reducing the need for renal replacement therapy – often unavailable in low-resource settings.
Despite the high AKI rate among paediatric patients in our study, all affected children showed clinical improvement. A total of 5 patients with severe malaria AKI were admitted to the day unit and received parenteral treatment with subsequent improvement, suggesting that early recognition and supportive care may be effective. It is also possible that some AKI cases were related to prior use of non-steroidal anti-inflammatory drugs, commonly used as antipyretics in the region. Further research is needed to better understand the relationship between malaria and AKI and to inform integration of renal function assessment into paediatric malaria management.
Our results highlight the vulnerability of the paediatric population due to an immature immune system and underscore the need for focused screening and therapeutic interventions. In the adult population, the AKI detection rate was 0.6%. Recording of vital signs on presentation was incomplete for most patients, and decision-making to offer POC Cr testing was rarely based on objective physiological parameters. This low AKI detection rate does not justify POC Cr screening based solely on clinical judgement and supports the need for further studies with risk assessment based on physiological observations.
Importantly, no additional workforce was allocated for this study, and the findings reflect routine practices in a typical primary care setting in Nigeria [16]. The lack of systematic collection and recording of vital signs at presentation to guide clinical practice highlights a gap in acute and emergency care that must be addressed through workforce planning, training, and system-level interventions in future AKI research.
There are several limitations to our study. First, although we assessed POC Cr accuracy in adults, we did not perform a similar validation in children. It is possible that different measurement biases exist at lower creatinine levels that may have contributed to the higher burden of paediatric AKI observed in this study. Otherwise, the tests were performed by the same clinical staff under consistent quality controls and did not appear to overestimate creatinine in adults. Second, in this study we defined AKI using the upper limit of the normal creatinine range, following UK AKI guidance based on recommendations from the Paediatric Laboratory Medicine Network (PaLMnet) meeting in 2014 [9]. This approach has also been applied in large prospective studies of children with malaria in Uganda [17]. However, using the upper limit of the normal reference range as the baseline creatinine may lead to under-detection of AKI in malnourished African children, compared with the approach reported by Batte et al. [18] that uses a median reference value, and which has shown promising validity in Ugandan paediatric patients [18], identifying 2.5-fold higher rates of AKI. It is worth noting that adopting the median value instead of the upper limit of normal would have led to even higher estimates of paediatric AKI rates in our cohort.
Third, the study protocol was not followed consistently, resulting in incomplete collection of physiological observations and severe malaria characteristics. Consequently, we are unable to provide a detailed description of the severity of malaria presentations. In addition, data on co-infections, prior NSAID use, and herbal medicine intake – which could all influence kidney function – were not systematically collected or recorded. Follow-up information on renal function or long-term malaria-related outcomes was also not obtained. Furthermore, we lack data on how many patients meeting the criteria for high AKI risk were tested, or whether individuals testing positive for malaria were more likely to receive POC Cr testing. In light of these limitations, the results should be interpreted with caution.
Conclusion
AKI was present in over half of paediatric malaria cases in our study, highlighting it as a common and potentially under-recognised complication. These results support the need for further research aiming at evaluating POC Cr testing in paediatric patients and investigating the impact of AKI across the spectrum of malaria severity, alongside the development of standardised clinical protocols that incorporate physiological observations. Such research can inform future integration of the KDIGO AKI definition into WHO malaria guidelines [19]. Focused efforts are essential to improve diagnosis and management of malaria-associated AKI, especially in vulnerable paediatric populations in low-resource settings.
Acknowledgements
The project was conducted under the Sister Center Renal Programme, supported by ISN. Point-of-care creatinine devices were provided by the Salford Renal Department, and consumables were provided free of charge by NOVA Biomedical.
Statement of Ethics
This study was performed in accordance with the Declaration of Helsinki. This study was approved by the University of Port Harcourt Research Ethics Committee – Approval No. UPTH/ADM/90/S.II/VOL XI/746, 7 May 2019. All parents, guardians, or next of kin provided verbal informed consent for the minors to participate in this study. All adult participants provided verbal informed consent to participate in this study. Oluo Doris Chiemela, Siyeofori Dede, Kinikawo Green, and Adaeze Oreh are not available to confirm co-authorship. The corresponding author Dimitrios Poulikakos guarantees Oluo Doris Chiemela, Siyeofori Dede, Kinikawo Green and Adaeze Oreh co-authorship status and the accuracy of the author contribution and conflict of interest statements.
Conflict of Interest Statement
D.P. received support for attending conferences by NOVA Biomedical. All other authors declare no conflict of interest.
Funding Sources
Educational network supported by ISN Sister Centre Renal Programme and consumables for point-of-care devices provided free of charge by NOVA biomedical.
Author Contributions
Yetunde Ugwem-Ikuru, Vivean Laurent-Ordu, and Oluo Doris Chiemela: data collection and analysis. Siyeofori Dede, Kinikawo Green, and Adaeze Oreh: study design. Pedro Emem-Chioma, Ibi Erekosima, David Lewis, and Dimitrios Poulikakos: conceptualisation, study design, data analysis, review, and editing.
Funding Statement
Educational network supported by ISN Sister Centre Renal Programme and consumables for point-of-care devices provided free of charge by NOVA biomedical.
Data Availability Statement
The data supporting this study’s findings are not publicly available due to privacy considerations but can be obtained from the corresponding author upon reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data supporting this study’s findings are not publicly available due to privacy considerations but can be obtained from the corresponding author upon reasonable request.
