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Effect of drug furosemide on progression of early onset of acute kidney failure in sick children- A comparative controlled study

Effect of furosemide on progression of early onset of acute kidney injury in critically ill children- A randomized double blinded, placebo controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/09/007321
Enrollment
220
Registered
2016-09-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- children aged (corrected age) 1 month to 12 years with Early onset AKI

Interventions

Intervention1: Intravenous furosemide: Intravenous furosemide shall be given as infusion of 0.05 mg per kg per hour to 0.4 mg per kg per hour (equal to 0.05 mlper kg per hour to 0.4 ml per kg per hour

Sponsors

JIPMER intramural grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children aged (corrected age) 1 month to 12 years of adult parents with the following criteria with Early onset AKI as defined by p RIFLE classification (Risk stage either urine output or serum creatinine criterion or both) and achieved immediate resuscitation goals (as directed by the treating physician) including fluid resuscitation AND/OR vasoactive therapy to achieve capillary refill of 5th percentile mean arterial blood pressure (MABP) for age, sex and length or height, normal pulses volume with no differential between peripheral and central pulses. Central venous pressure >=8 cmH2O (if measured), central venous oxygen saturation >=70% (if measured) AND/OR cardiac index between 3.3 and 6.0 L/min/m2 (if measured).

Exclusion criteria

Exclusion criteria: 1. Patient with >= Stage 4 chronic kidney disease (defined by an estimated glomerular filtration rate 2. Patient with acute pulmonary edema requiring urgent use of furosemide or RRT or patient already receiving continuous furosemide infusion irrespective of dose and duration. 3. Patient with known or suspected drug allergy to furosemide. 4. Patient with known or suspected obstructive etiology for AKI.

Design outcomes

Primary

MeasureTime frame
To compare proportion of critically ill children with â??Riskâ?? stage progressing to higher stage (Injury or Failure) of AKI as per p-RIFLE classification in the furosemide infusion group versus placebo infusion groupTimepoint: At PICU discharge.

Secondary

MeasureTime frame
Fluid balance as percentage of fluid overload and side effects of furosemide and stay in PICU and hospitalTimepoint: At PICU discharge and 28 days;Patient requiring renal replacement therapy (including duration) and urine and blood NGALTimepoint: At PICU discharge and 28 days;Time taken to achieve the operational definition of renal recovery and mortalityTimepoint: At PICU discharge and 28 days

Countries

India

Contacts

Public ContactDR R RAMESH KUMAR

JIPMER

krramesh_iway@yahoo.co.in7373739142

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026