Characteristics of studies retrieved on paediatric fluid resuscitation

Study	Methods	Participants	Interventions	Outcomes	Comments
Akech 200640	Controlled trial (quasi-randomisation). Sequential blocks of 10. No blinding. No allocation concealment. Follow-up to discharge from hospital for adverse events	88 children with malaria age >3 months with metabolic acidosis (base deficit >8 mmol/l); Hb >50 g/l; plus clinical feature of shock	Gelofusine (n=44); 4.5% HAS (n-44). Admission: bolus 20 or 40 ml/kg (if hypotensive ). Further 20 ml/kg if shock present at 1 hour	Resolution of shock. Resolution of acidosis at 1 and 8 hours. In hospital death. Adverse events. Neurological sequelae. Allergic reactions	Quasi-randomisation. Inadequate allocation concealment. Inadequate sequence generation. Colloid v colloid comparison
Cifra 200344	Quasi-randomised trial. Patients allocated “systematically.” Alternate allocation. No information on blinding. All outcomes in hospital. No loss to follow-up	Dengue shock syndrome; 27 children	6% Hydroxyethyl starch (Haes-Steril) (n=11); Ringers lactate (n=16)	Duration of control of shock, frequency of recurrence of shock, length of ICU stay, mortality	Inadequate allocation concealment. Inadequate sequence generation
Dung 199941	RCT. Allocation concealment with numbered opaque envelopes. Double blind with opaque envelopes in blocks of 10. Fluid masked with black opaque containers. Follow-up to hospital discharge	Dengue shock syndrome; 50 children aged 5-15 years who had not received IV fluid therapy during current illness	Dextran 70 (n=12); 3% Gelafundin (n=13); Ringers lactate (n=13); normal saline (n=12). Bolus 20 ml/kg over 1 hour, 10 ml/kg over 2nd hour	Recovery from shock (pulse pressure ≤20 mm Hg), duration and No of episodes of shock, improvements in cardiac output and packed cell volume, and, requirements for further fluid resuscitation	Adequate allocation concealment and adequate sequence generation. No deaths
Maitland 200337	Controlled trial (quasi-randomisation). Alternate systematic allocation. Allocation also based on availability of study fluid. No blinding. No allocation concealment. Follow-up to 48 hours after admission for haemodynamic variables and blood gases (acidosis)	53 children with severe malaria aged 6 months-12 years. Metabolic acidosis (base deficit >8 mmol/l). Divided into severe anaemia (Hb <50 g/l) or no severe anaemia	0.9% saline (n=20); 4.5% HAS (n=32); saline and HAS (n=1). Aliquots of 10 ml/kg given to achieve CVP 5-8 cm H2O. Bolus of 10-40 ml/kg given over 1st hour after admission	Resolution of acidosis/base deficit reduction at 8 hours, CVP 5-8 cm H2O and, improvement of haemodynamic indices	Inadequate allocation concealment and inadequate sequence generation
Maitland 200538	RCT. No blinding. Allocation concealment with opaque envelopes. Follow-up to discharge from hospital for adverse events	150 children with severe malaria, age 6 months-12 years. Metabolic acidosis (base deficit >8 mmol/l), Hb >50 g/l	0.9% saline (n=61), 4.5% HAS (n=56), no bolus (n=33). Moderate acidosis (base deficit 8-15mmol/l): received 20 ml/kg (saline and HAS) or no bolus (control). Severe acidosis (base deficit >15 mmol/l) received 40 ml/kg, no control group. Rescue if hypotensive or oliguria	Resolution of acidosis/base deficit reduction at 8 hours, in-hospital death, neurological sequelae, need for rescue therapies	Adequate allocation concealment. Computer generated randomisation sequence produced by an independent statistician, information provided by authors of review who conducted studies
Maitland 200539	RCT. Allocation concealment with sealed card system. No blinding. Follow-up to discharge from hospital for adverse events	61 children with symptomatic severe malaria anaemia, age >2 months plus metabolic acidosis (base deficit >8 mmol/l)	0.9% saline (n=20), 4.5% HAS (n=23), or control (no bolus) (n=18). Bolus 20 ml/kg of normal saline or albumin over 1 hour while awaiting blood transfusion.	Resolution of acidosis/base deficit reduction at 8 hours, in-hospital death, neurological sequelae	Adequate allocation concealment. Computer generated randomisation sequence produced by independent statistician, information provided by authors of review who conducted studies
Ngo 200142	RCT. Double blind with fluid masked using black opaque containers. Allocation concealment with opaque envelopes in blocks of 10. Follow-up to hospital discharge	230 children with Dengue shock syndrome, aged 5-15 years, had not received IV fluid therapy during current illness	Dextran 70 (n=55), 3% gelatin (Gelafundin) (n=56), Ringers lactate (n=55), or normal saline (n=56). Bolus 20 ml/kg over 1 hour, 10 ml/kg over 2nd hour. 8 children had dengue haemorrhagic fever grade IV and not randomised	Recovery from shock (pulse pressure ≤20 mm Hg), duration and No of episodes of shock, improvements in cardiac output and packed cell volumes, requirements for further fluid resuscitation	Adequate sequence generation and adequate allocation concealment. No deaths
Upadhyay 200545	RCT. Open label, randomised. Random tables used to generate numbers. Allocation concealment with sealed envelopes and kept with one investigator. Monitoring till 6 hours after stability then till recovery	60 children with sepsis, age 1 month-12 years. Septic shock, without clinical evidence of organ failure at admission or hypotension	Normal saline (n=31) or, Haemaccel (n=29). Bolus 20 ml/kg of 0.9% saline or Haemaccel till haemodynamically stable or if CVP >10 mm Hg	Haemodynamic stabilisation (heart rate, capillary refill time, pulse volume, blood pressure in normal range), plasma volume at end of fluid resuscitation, incidence of organ dysfunction	Adequate allocation concealment and adequate sequence generation
Wills 200543	RCT. Computer generated random numbers. Double blind treatment packs in sealed special cardboard containers, identified only by study number. Independent staff not involved in care prepared packs and randomisation. Pre-sealed and pre-labelled envelopes used in emergency. Allocation concealment. Follow-up to discharge from hospital	512 children with clinical dengue shock syndrome, aged 2-15 years	Ringers lactate (n=128), 6% Detran70 (n=193), or 6% hydroxyethyl starch (n=191). Group 1=(moderate shock: pulse pressure >10 and ≤20 mm Hg) Dextran, starch, or Ringers lactate. Group 2=(severe shock: pulse pressure <10 mm Hg) allocated to Dextran or starch and given 15 ml/kg over 1 hour, 10 ml/kg over 2nd hour	Requirement for rescue colloid at any time after infusion of study fluid, time taken to achieve initial cardiovascular stability (pulse pressure ≥25 and systolic blood pressure ≥ 80 mm Hg for minimum of 2 hours), volumes of rescue colloid and total parenteral fluid required, No of days in hospital, change in packed cell volume, allergic reactions	Adequate sequence generation and adequate allocation concealment

RCT=randomised controlled trial; Hb=haemoglobin; HAS=human albumin solution; CVP=central venous pressure; ICU=intensive care unit.