Methods |
Randomised, open controlled study
I. Blinding of randomisations ‐ can't tell
II. Blinding of intervention ‐ no
III. Blinding of outcome measure assessment ‐ no
IV. Complete follow‐up‐ yes |
Participants |
12 infants born at </= 28 weeks GA with hyperkalaemia defined as central non haemolyzed serum K+ of > 7 mmol/L
Urine output (ml/kg/hr) was not reported
Study period May 1, 1989, and December 31, 1989
Single centre, the US |
Interventions |
7 infants [mean (SD) GA 24.8 +/‐ 1.5 weeks, BW 780 +/‐ 160 g ] received glucose‐insulin (human insulin with 5% albumin). The insulin was "piggybacked" into the existing i.v. fluids by means of a syringe infusion pump, starting at a rate of 0.1 ml/hr to deliver a dose of 0.05 to 0.1 IU/kg/hr
5 infants [mean (SD) GA 23.8 +/‐ 0.8 weeks, BW 650 +/‐ 60 g] received sodium polystyrene sulphonate (Kayexalate) prepared in a 25% sorbitol solution and given rectally in a dose of 1 gm/kg every 6 hours |
Outcomes |
Mortality, treatment failure (increase in K+ concentration > 0.5 mmol/L or failure to decrease K+ to < 7mmol/L, cardiac arrhythmia, hypoglycaemia (< 40 mg/dl; 2.2 mmol/L) |
Notes |
In 4 of the 5 Kayexalate‐treated infants in whom treatment was considered to have failed, a glucose‐insulin therapy was added. All 4 responded with decreased central K+ concentration within 6 hours after glucose‐insulin was added |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomised, open controlled study |
Allocation concealment (selection bias) |
Unclear risk |
Blinding of randomisations ‐ can't tell |
Blinding (performance bias and detection bias)
All outcomes |
High risk |
Blinding of intervention ‐ no |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Blinding of intervention ‐ no |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Blinding of outcome measure assessment ‐ no |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow‐up ‐ yes |