Balanced salt solutions versus saline
Phase 4
- Conditions
- Health Condition 1: I958- Other hypotension
- Registration Number
- CTRI/2022/09/045580
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children 2 month to = 17 years with features of septic shock –defined as children who have a suspected infection and have at least two clinical signs of decreased perfusion with or without hypotension.
Exclusion Criteria
1.Children receiving fluid boluses before enrollment
2.Children with cardiogenic shock
3.Known patient with chronic kidney disease with baseline deranged renal function (eGFR < 90 ml/1.73 m2/min)
4.Severe malnutrition
5.Children whose parents refuse to give an informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To examine if use of any one of these balanced crystalloids - Ringers lactate, Ringers acetate or Plasmalyte A is superior to Saline in terms of lower incidence of acute kidney injury (defined as increase in serum creatinine by 0.3mg/dL within 48 hours or to 1.5 times baseline or more within the last 7 days or urine output less than 0.5 mL/kg/h for 6 hours) 48 in the first seven days after initial fluid resuscitationTimepoint: Till 7 days of fluid resuscitation
- Secondary Outcome Measures
Name Time Method a)Incidence of hyperchloremia and metabolic acidosis at 6 and 24 hours <br/ ><br>b)Requirement of fluid boluses in first 6 hours and total fluids in first 24 hours, 48 hours and 72 hours. <br/ ><br>c)Proportion of patients achieving the pre-determined therapeutic end points at 6 hours after intervention. Time to achievement of therapeutic goals. <br/ ><br>d)In-ICU mortality rates <br/ ><br>Timepoint: Hyperchloremia assessed at 6, 24, 48, 72 hours and 7 days <br/ ><br>Total fluids received as boluses in first 6 hours and total fluids in 24 hours, 48 hours and 72 hours. <br/ ><br>Proportion of patients achieving therapeutic end points and time taken for resolution of shock. <br/ ><br>Mortality during ICU stay