Abstract
Background
Lung-protective ventilation in acute respiratory distress syndrome (ARDS) can lead to hypercapnia, an independent risk factor for increased mortality. Extracorporeal CO2 removal (ECCO2R) enables further reduction of ventilator intensity, but its routine use is limited due to safety concerns. In the current study, we evaluated the feasibility, efficacy, and safety of minimally invasive ECCO2R (miECCO2R) implemented via a renal replacement therapy (RRT) platform in patients with mild-to-moderate ARDS and refractory hypercapnia.
Methods
In this prospective single-center observational study, 20 ICU patients with persistent hypercapnia despite escalated ventilation received either standalone miECCO2R (n = 11) or miECCO2R combined with continuous RRT (n = 9). As a primary outcome, efficacy of miECCO2R was assessed. Moreover, ventilator parameters, disease severity, renal function, and adverse events were evaluated as secondary outcome parameters over a time-course of five days upon initiation of miECCO2R.
Results
miECCO2R led to a rapid and sustained reduction in PaCO2 levels from 71.4 mm Hg to 51.6 mm Hg within 24 h. This was accompanied by normalization of pH, and the median CO2 clearance rate was 64.5 mL/min. Driving pressure decreased significantly from 22 cm H2O to 15 cm H2O by day 5, while oxygenation remained stable. The standalone miECCO2R treatment group demonstrated faster CO2 reduction, probably due to higher blood flow rates. There were no severe adverse events related to either the device or the therapy. Circuit clotting was managed by system exchange, without clinical consequences for the patients. Platelet counts declined moderately, but no major bleeding complications occurred.
Conclusions
miECCO2R delivered via an RRT platform appears to be a safe and effective method of controlling hypercapnia and facilitating lung-protective ventilation in patients with ARDS. These findings need to be supported by further randomized controlled trials that can more definitely demonstrate the impact of miECCO2R on clinical outcomes.
Supplementary Information
The online version contains supplementary material available at 10.1186/s13054-026-06062-1.
Keywords: ARDS, CO2, CO2 removal, ECCO2R, miECCO2R, CRRT, Driving pressure
Background
Lung-protective mechanical ventilation is pivotal in the treatment of acute respiratory distress syndrome (ARDS) [1]. Such strategies mitigate ventilator-induced lung injury but can cause hypercapnia due to insufficient carbon dioxide (CO2) clearance. Elevated CO2 levels are an independent risk factor for increased mortality in various pulmonary diseases and in mechanically ventilated patients in intensive care unit (ICU) settings [2, 3]. Recent clinical trials show that extracorporeal CO2 removal (ECCO2R) is effective in limiting CO2 accumulation in patients with ARDS and maintaining lung-protective ventilation, even under ultra-protective tidal volumes [4–9]. However, severe adverse events have also been reported, some of which may be attributable to technological limitations [10]. Accordingly, the most recent European Society of Intensive Care Medicine guidelines on ARDS do not recommend routine ECCO2R use [1]. Instead, it is recommended that the potential benefits and harms of ECCO2R in this patient group will be evaluated in the setting of prospective studies [8]. In clinical practice, increasing ventilator settings, even over recommended limits, often fail to control increasing CO2 levels in patients with acute respiratory failure. In such cases, minimally invasive ECCO2R (miECCO2R), operated at very low blood flow rates (100–400 mL/min), similar to those employed during renal replacement therapy (RRT), may be valuable for CO2 removal. A previous report by the current researchers described the feasibility and safety of ECCO2R delivered via a RRT platform in four patients with COVID-19–associated ARDS and refractory hypercapnia, demonstrating rapid CO2 reduction [11]. In addition, the successful use of low blood flow rates during ultraprotective ventilation in combination with RRT was recently reported [12]. The present observational study expands on those findings through quantitative analyses of the potential of miECCO2R at very low blood flow rates, with or without RRT, in mechanically ventilated mild-to-moderate ARDS cases with hypercapnia.
Methods
This prospective, single-center, observational study included 20 patients diagnosed with mild-to-moderate ARDS and persistent hypercapnia despite escalation of ventilation settings admitted to the medical ICU at the University of Giessen Lung Center between May 2020 and January 2025. Patients received miECCO2R as standalone therapy (n = 11; 55%) or in combination with continuous RRT (CRRT) (miECCO2R/CRRT) (n = 9; 45%). Initiation of CRRT was at the discretion of the treating physician and guided by Kidney Disease: Improving Global Outcomes (KDIGO) recommendations (detailed criteria are provided in eTable 1).
miECCO2R was performed using a polymethylpentene hollow fiber gas-exchange membrane (multiECCO2R; Eurosets, Medolla, Italy) and the multiFiltrate CRRT system (Fresenius Medical Care, Bad Homburg, Germany). For standalone miECCO2R, blood flow was set at 300–400 mL/min. For combined miECCO2R/CRRT, continuous veno-venous hemodialysis was applied with blood flow set to 100–200 mL/min. According to the manufacturer’s instructions, the multiECCO2R membrane was positioned downstream of the hemofilter (Ultraflux AV 1000S; Fresenius Medical Care, Bad Homburg, Germany) within the extracorporeal circuit, and sweep gas flow was set at approximately 15-fold the blood flow rate (4.5–6 L/min and 1.5–3 L/min for miECCO2R and combined miECCO2R/CRRT, respectively) [11]. The miECCO2R group received systemic anticoagulation with systemic heparin or argatroban (target aPTT 60–80 s), whereas the miECCO2R/CRRT group received regional citrate and prophylactic systemic anticoagulation therapy (detailed protocols are provided in the Supplementary Methods).
Demographics and baseline clinical characteristics were recorded at enrolment. The clinical variables analyzed were respiratory rate, mean arterial pressure, need for vasopressor (norepinephrine) administration, arterial partial pressure of CO2 (PaCO2), CO2 clearance rate, pH, bicarbonate concentration, driving pressure, arterial partial pressure of O2 (PaO2), peak inspiratory pressure (PInsp), positive end-expiratory pressure (PEEP), and fraction of inspired O2 (FiO2). Clinical severity scores and the laboratory parameters white blood cell and platelet counts, serum creatinine, urea, and hemoglobin were also analyzed. Data were collected at baseline, 1 h, 4 h, 24 h, and daily thereafter. No sample size calculation was conducted, as the study did not involve formal hypothesis testing and was intended to provide descriptive and exploratory insights only. Unless specified differently, values are presented as median (IQR 25%–75%). Repeated measures were analyzed with the Friedman, Skillings-Mack test and post-hoc Wilcoxon signed-rank test. Statistical significance was set at p < 0.05. Statistical analyses were performed using SPSS Statistics (IBM, Version 29.0.1.1) and the R software (Version 4.4.1; tidyplot package).
Results
Patients and disease course
The demographic and clinical characteristics of the patients and the subgroups at inclusion are presented in eTable 2 and eTable3. Although the original observation period was 72 h, the analysis was extended to 5 days based on the observed median treatment duration. By day 5, miECCO2R was discontinued in two patients who showed clinical improvement, while three patients died from multiorgan failure.
Overall treatment outcomes
The mean extracorporeal blood flow rate of the miECCO2R system was 291.1 ± 114.8 mL/min across all patients and study visits: 380.7 ± 53.2 mL/min in the miECCO2R-alone group and 173.2 ± 46.8 mL/min in the miECCO2R/CRRT-combination group. The mean sweep gas flow rate was 4.4 ± 1.7 L/min for the overall cohort: 5.7 ± 0.8 L/min in the miECCO2R-alone group and 2.6 ± 0.7 L/min in the miECCO2R/CRRT-combination group (Table 1).
Table 1.
Operational characteristics of miECCO2R
| Time | Blood flow (mL/min) | Sweep gas flow (L/min) | aPTT (sec) | Post-membrane iCa2+ (mMol/L) | ||||
|---|---|---|---|---|---|---|---|---|
|
miECCO2R (N = 11) |
miECCO2R/CRRT (N = 9) |
miECCO2R (N = 11) |
miECCO2R/CRRT (N = 9) |
miECCO2R (N = 11) |
miECCO2R/CRRT (N = 9) |
miECCO2R (N = 11) |
miECCO2R/CRRT (N = 9) |
|
| 1 h | 400 (400–400) | 175 (100–200) | 6.0 (6.0–6.0) | 2.5 (1.5–3.0) | 71 (57–88) | 42 (34–46) | 1.13 (1.00–1.16) | 0.30 (0.26–0.34) |
| 24 h | 400 (390–400) | 175 (140–200) | 6.0 (6.0–6.0) | 2.5 (1.9–3.0) | 88 (65–116) | 44 (37–48) | 1.12 (1.03–1.16) | 0.28 (0.25–0.31) |
| 48 h | 400 (390–400) | 175 (140–200) | 6.0 (6.0–6.0) | 2.5 (1.9–3.0) | 69 (64–82) | 41 (36–48) | 1.13 (1.02–1.19) | 0.30 (0.28–0.31) |
Data are presented as median (25%–75% interquartile range)
CRRT: continuous renal replacement therapy, miECCO2R: minimally invasive extracorporeal CO2 removal, iCa2+: ionized calcium
Arterial blood gas analysis revealed a rapid reduction in PaCO2, from 71.4 mm Hg (IQR: 64.2–77.5) at baseline to 51.6 mm Hg (IQR: 45.1–57.7) within the first 24 h of miECCO2R therapy, accompanied by normalization of blood pH (eTable 4). The highest CO2 clearance rates were observed during the first hour of miECCO2R treatment, with the highest value being 82.9 mL/min (IQR: 50.7–110.7). Overall, the median CO2 clearance across all study visits was 64.5 mL/min (IQR: 41.1–91.9).
Ventilator parameters demonstrated a significant reduction in driving pressure, with the greatest decrease observed on day 5: 22 cm H2O (IQR: 19–22) at baseline and 15 cm H2O (IQR: 13–18) on day 5. This was achieved through a gradual decrease in PInsp with maintenance of stable PEEP (eTable 5). Analysis of lung mechanics revealed an increase in dynamic respiratory compliance and a reduction in mechanical power and ventilatory ratio over the observation time-course. The reduction in PaCO2 was achieved under preservation of arterial oxygenation. While PaO2 remained stable, the PaO2/FiO2 ratio increased to 185.0 (IQR: 148.9–252.5) by day 5. These improvements were accompanied by a reduction in vasopressor requirements and maintenance of a mean arterial pressure above 65 mmHg.
No significant changes were observed in clinical severity scores, including SOFA, APACHE II, and SAPS II, throughout the study period. Platelet counts significantly reduced from 263 × 10⁹/L (IQR: 211–344) at baseline to 198 × 10⁹/L (116–256) at day 3.
Standalone miECCO2R versus combined miECCO2R/CRRT
Compared to combined miECCO2R/CRRT, standalone miECCO2R resulted in significantly faster PaCO2 reduction, normalization of pH, greater CO2 clearance, and decreased driving pressure, particularly within the first 24 h (Fig. 1). This probably reflects the higher blood flow rates, one of the major determinants of CO2 removal efficacy, with standalone miECCO2R, that enabled greater CO2 elimination and may also be influenced by greater illness severity in the combined treatment group, as indicated by higher SAPS II and APACHE II scores. Serum creatinine remained largely stable over time in the standalone miECCO2R group. As expected, the combination group demonstrated a significant improvement in serum creatinine.
Fig. 1.
Key treatment outcomes of miECCO2R with and without CRRT. The graphs depict the course of PaCO2 (A), CO2 clearance (B), pH (C), driving pressure (D), and clinical scores (E and F) in patients with mild-to-moderate ARDS and refractory hypercapnia receiving either miECCO2R as standalone therapy (blue) or in combination with CRRT (red). The boxplots display median values with 25%–75% interquartile ranges as well as minimum and maximum values at baseline and up to 5 days upon initiation of miECCO2R. *p < 0.05, **p < 0.01, ***p < 0.001, compared to baseline (A, C, and D) or miECCO2R compared to miECCO2R/CRRT (B and E)
Treatment-related adverse events
No severe adverse events related to miECCO2R therapy were observed in either group. In one patient, a single bleeding episode occurred at the tracheostomy site, but platelet counts and coagulation parameters were within the normal or predefined target range at the time of the event. In another case, escalation to extracorporeal membrane oxygenation was required due to rapid clinical deterioration with hypoxemia. This was considered unrelated to miECCO2R therapy and not classified as a treatment-associated severe adverse event. Clot formation within the extracorporeal circuit occurred in 4 cases (for additional information please refer to the Supplementary Appendix). When considering the total number of circuits used, the effective clotting rate per circuit was 7.7% and therefore within the range reported for CRRT systems, where circuit lifespan is typically limited to approximately 26–47 h depending on the anticoagulation strategy, including a median of ~ 47 h with regional citrate anticoagulation in CRRT [13]. Similar ranges have been reported in a recent study using CRRT combined with ECCO2R [12]. In each instance, clotting was successfully resolved by changing the CO2 filter or the miECCO2R circuit, without further clinical consequences.
Discussion
The present findings suggest that miECCO2R is a safe and effective addition to mechanical ventilation for patients with mild-to-moderate ARDS and refractory hypercapnia. CO2 levels and ventilator pressures were significantly reduced without any compromise in oxygenation and hemodynamic stability or occurrence of major complications. Implementation of miECCO2R via an RRT platform was feasible, particularly in cases with indications for RRT.
Due to the high CO2 elimination rate despite ultra-low blood flow levels, normocapnia could be achieved in most patients within 24 h. This allowed for subsequent de-escalation of ventilation. This is of particular relevance, as it is known that both hypercapnia and injurious ventilation are independent risk factors of mortality in ICU patients requiring respiratory support [3, 14, 15].
The design of our study differs from previously published trials, in which the primary goal was to lower tidal volume while maintaining normal or slightly elevated PaCO2 with ECCO2R [4, 5, 16]. In our severely hypercapnic cohort, tidal volume was ~ 6 mL/kg; however, the driving pressure was well above the recommended levels at initiation of miECCO2R. Our primary objective was, therefore, to both reduce the markedly elevated PaCO2 levels and de-escalate ventilator pressures, thereby lowering the risk of barotrauma while preserving gas exchange. We were able to achieve both goals with standalone and combined treatments and, thereby, demonstrate the feasibility and benefits of miECCO2R by itself and when combined with RRT.
Patients in our study exhibited marked disease severity, with baseline SAPS II, SOFA, and APACHE II scores corresponding to an expected hospital mortality of approximately 50–70% [17–19]. In our collective, we observed a 45% 28-day mortality in patients receiving miECCO2R therapy with or without RRT. While our study was neither designed nor powered to detect a mortality benefit with miECCO2R, it is conceivable that achieving normocapnia and limiting barotrauma with a minimally invasive method and a potentially low incidence of adverse effects may lead to better outcomes in this patient group.
Major bleeding is a severe adverse event associated with ECCO2R [4, 10]. However, in our cohort, no major bleeding events were recorded. The use of an RRT platform as a “motor” of miECCO2R (a peristaltic pump) may be favorable in the context of hemolysis, as the centrifugal pumps regularly used for ECCO2R are associated with high rates of hemolysis at low blood flow levels [10].
While the present findings demonstrate the benefits of miECCO2R in the examined patient group, certain limitations need to be considered, such as the small sample size, the single-center design, the absence of a control group and the lack of standardized ventilatory management due to the explorative nature of the study. Also, the observational period was limited to five days after initiation of miECCO2R as at later time-points meaningful comparisons would have been progressively more difficult due to the increasing amount of missing data (smaller sample size over time). Moreover, patients requiring CRRT had an independent indication for renal support and may therefore represent a subgroup with more advanced organ dysfunction, as reflected by higher baseline SOFA scores, introducing potential selection bias. Importantly, in the group of combined miECCO2R and CRRT extracorporeal blood flow rates were significantly lower, whereas the rate of ARDS secondary to COVID-19 was higher, when compared to standalone miECCO2R; accordingly, comparisons between groups should be interpreted with caution.
Conclusion
The delivery of miECCO2R via an RRT platform presents a scalable, resource-efficient strategy in mechanically ventilated patients with mild-to-moderate ARDS. A multicenter prospective randomized controlled trial is necessary to demonstrate the effect of miECCO2R on clinical outcomes in this patient group.
Supplementary Information
Acknowledgements
The authors express their gratitude to the medical and nursing staff of the ICU at the University of Giessen Lung Center for their unwavering commitment to patient well-being. The completion of this project would not have been feasible without their invaluable support.
Abbreviations
- APACHE II
Acute physiology and chronic health evaluation score II
- ARDS
Acute respiratory distress syndrome
- CRRT
Continuous renal replacement therapy
- ICU
Intensive care unit
- miECCO2R
Minimally invasive extracorporeal carbon dioxide removal
- PaCO2
Arterial partial pressure of carbon dioxide
- PaO2
Arterial partial pressure of oxygen
- PEEP
Positive end-expiratory pressure
- PInsp
Peak inspiratory pressure
- RRT
Renal replacement therapy
- SAPS II
Simplified acute physiology score II
- SOFA
Sequential organ failure assessment score
Author contributions
IV and FHS designed the trial. VK and ES collected clinical data. VK, FHS and IV generated the tables and figures for publication. GO, MH, KT, FHS and IV recruited patients. VK, REM, SH, MH, KT, WS, FHS and IV interpreted data. VK, FHS and IV wrote the manuscript. All authors read an approved the final manuscript.
Funding
Open Access funding enabled and organized by Projekt DEAL. This work was supported in part by grants from the German Federal Ministry of Education and Research (German Center for Lung Research [DZL/PALI]) and the German Research Foundation (EXC 2026, project ID: 390649896).
Data availability
The datasets used and analyzed are during the current study are available from the corresponding author on reasonable request.
Declarations
Ethics approval and consent to participate
The study protocol was approved by the Ethics Committee of the Medical Faculty of Justus Liebig University Giessen (AZ 63/20) and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from the patients or their legally authorized representatives. The study is prospectively registered at ClinicalTrials.gov (NCT04351906).
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests. IV has received research funding from Fresenius Medical Care Deutschland GmbH. Fresenius Medical Care Deutschland GmbH had no role in the trial design, data collection or data interpretation.
Footnotes
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Vitalii Kryvenko and Faeq Husain-Syed contributed equally to this work and share first authorship.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The datasets used and analyzed are during the current study are available from the corresponding author on reasonable request.