Study of normal saline versus Ringerâ??s Lactate for managing adult patients with infection and organ dysfunction in emergency medical services

Phase 3

• Conditions: Health Condition 1: null- Sepsis

• Registration Number: CTRI/2018/03/012372
• Lead Sponsor: Postgraduate Institute of Medical Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients with age 18 years or more

2.Having increase in sequential organ failure assessment (SOFA) score of 2 points or more along-with documented source of infection anywhere in body proven either clinically or by laboratory/radiological investigation/s

3.Who give consent for participation in the study, are eligible for inclusion in the study

Exclusion Criteria

1. Patients less than 18 years;

2. Pregnancy

3. Patients on admission having baseline elevated chloride and potassium levels

4. Patients who are already diagnosed with Chronic Kidney or Liver disease

5. Patients who have already received initial fluid resuscitation before reporting to emergency medical services for a period exceeding 24 hours

6. Patients receiving or expected to receive RRT within 6 hours

7. Patients who are on maintenance hemodialysis for Chronic Kidney disease

8. Patients having component of concurrent cardiogenic shock

9. Not willing to give written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To find out incidence of hyperchloremia at 24 hours from the time of randomization and during hospital stay in adult patients with confirmed diagnosis of sepsis presenting in emergency medical services receiving either Normal saline or Ringerâ??s Lactate for fluid resuscitation during first 24 hours post randomizationTimepoint: At 24 hours from the time of randomization and at time of discharge

Secondary Outcome Measures

Name	Time	Method
Secondary objectives are to ascertain: <br/ ><br>â?¢Incidence of AKI at 24 hours, 48 hours from the time of randomization and during their hospital stay <br/ ><br>â?¢Change in pH from baseline to 6, 12, 24, 48 hours after randomization and lowest pH documented during their hospital stay <br/ ><br>â?¢Change in coagulation parameters from baseline to 24, 48 hours after randomization and worst parameters documented during their hospital stay <br/ ><br>â?¢Hospital mortality and 30 day mortality <br/ ><br> <br/ ><br>Timepoint: At 6, 12, 24, 48 hours from the time of randomization and at time of discharge <br/ ><br> <br/ ><br>