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

0.9% Saline v/s Ringerâ??s Lactate for fluid resuscitation in adult sepsis patients in emergency medical services: An open label Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012372
Enrollment
158
Registered
2018-03-06
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- Sepsis

Interventions

Intervention1: Ringer Lactate: It is a balanced Crystalloid. Volume resuscitation would be done according to recommendations provided in surviving sepsis campaign guideline-2016. Initially patie

Sponsors

Postgraduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

India

Contacts

Public ContactDr Rithvik Golla

Postgraduate Institute of Medical Education and Research

susheelbhutungru@gmail.com7087008184

Outcome results

None listed

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