| Methods |
Randomised, controlled study
I. Blinding of randomisations ‐ can't tell (See notes)
II. Blinding of intervention ‐ no
III. Blinding of outcome measure assessment ‐ no
IV. Complete follow‐up‐ yes |
| Participants |
40 VLBW infants with non‐oliguric hyperkalaemia (K+ > 6 mmol/L) in the first few days of life after birth
Single centre, Taichung, Taiwan
Study period not stated |
| Interventions |
20 infants mean (SD) GA 27.4 (1.8) weeks; BW mean (SD) 935 (259) g; mean (SD) urine output 5.4 (1.3) (ml/kg/hr) received regular insulin (Actrapid Human, Novo Nordisk)
The ratio of infused glucose to regular insulin was 10‐15 g of glucose to 1 unit of regular insulin, and the total glucose infusion rate of each infant was maintained at greater than 6 mg/kg/min. Insulin administration was adjusted according to blood sugar levels
20 infants mean (SD) GA 28.4 (2.4) weeks; BW mean (SD) 1065 (214); mean (SD) urine output 5.5 (0.9) (ml/kg/hr) received sodium polystyrene sulphonate (Kayexalate)
Kayexalate was prepared in normal saline solution with the ratio of g 1 g Kayexalate to 2 ml of normal saline and the administered dose was 1 g/kg body weight given rectally every 4 hours
Both groups received electrolyte free solution of glucose in the first 3‐4 days or until hyperkalaemia subsided
Therapy was discontinued when serum K+ was < 6 mmol/L for 6 hours
No infant had IVH prior to enrolment |
| Outcomes |
Cardiac dysrhythmias
IVH grade >/= II by cerebral ultrasound scan
Peak serum K+, duration of hyperkalaemia
Hypo (< 40 mg/dl) and hyperglycaemia (> 150 mg/dl) |
| Notes |
Infants were randomly assigned to one of two groups, no details were provided
None of the infants had IVH prior to study entry |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomised, controlled study |
| Allocation concealment (selection bias) |
Unclear risk |
Blinding of randomisations ‐ can't tell (see notes) |
| 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 |
