NCT07240701

Normal Saline Versus Ringer's Lactate for Initial Fluid Resuscitation in Sepsis

A Prospective, Single-Center, Randomized Controlled Trial Comparing Normal Saline and Ringer's Lactate for Initial Fluid Resuscitation in Adult Patients With Sepsis in the Emergency Department

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Egemen Yildiz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to determine if the type of intravenous fluid used for initial resuscitation affects the short-term outcomes of adult patients with sepsis who are treated in the emergency department. The main questions it aims to answer are: Does using Ringer's lactate instead of 0.9% sodium chloride (normal saline) reduce 24-hour mortality in patients with sepsis? Does the type of fluid influence other short-term outcomes, such as the need for vasopressors, mechanical ventilation, hemodialysis, and length of hospital stay? Researchers will compare two groups of participants: * The Ringer's lactate group (intervention group) * The 0.9% sodium chloride group (control group). Participants will: * Receive either Ringer's lactate or normal saline for initial fluid resuscitation as part of standard sepsis care. * They will be observed for 24 hours to assess survival and other early outcomes.

Detailed description

This prospective, single-center, randomized, double-blind, controlled clinical trial aims to compare the effects of Ringer's lactate and 0.9% sodium chloride (normal saline) solutions for initial fluid resuscitation in adult patients with sepsis who are treated in the emergency department. The study is conducted in accordance with the Surviving Sepsis Campaign's 2021 guidelines, which emphasize the importance of early and adequate crystalloid resuscitation in sepsis management. Although both solutions are widely used in clinical practice, evidence regarding their comparative effects on short-term mortality and organ dysfunction is inconsistent. This study seeks to provide prospective, blinded data to clarify whether fluid type influences early outcomes in patients with sepsis. Participants who meet eligibility criteria will be randomized in a 1:1 ratio using a computer-generated sequence prepared by an independent staff member. To ensure blinding, study fluids will be provided in identical coded containers, and patients, treating clinicians, and investigators will remain unaware of the assigned fluid type throughout the study period. The assigned study fluid will be administered intravenously as an initial bolus according to clinical judgment. After completion of the initial bolus, all subsequent fluid therapy and additional treatments will follow standard institutional practice at the discretion of the treating physician. If clinical circumstances require breaking the study blind for patient safety reasons, the investigator will document the reason and unblind the allocation. There will be no delay in clinical management as a result of study participation.

Conditions

• Sepsis

Interventions

Type	Name	Description
OTHER	Ringer's Lactate	Intravenous infusion of Ringer's lactate solution for initial fluid resuscitation in sepsis. Each participant receives approximately 1000 mL of Ringer's lactate administered via a peripheral intravenous line over 30 to 60 minutes during the initial resuscitation phase. The intervention is performed once, and all subsequent management follows standard sepsis treatment protocols.
OTHER	Normal Saline (0.9% Sodium Chloride)	Intravenous infusion of 0.9% sodium chloride solution (normal saline) for initial fluid resuscitation in sepsis. Each participant receives approximately 1000 mL of normal saline administered via a peripheral intravenous line over 30 to 60 minutes during the initial resuscitation phase. The intervention is performed once, and all subsequent management follows standard sepsis treatment protocols.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: Turkey (Türkiye)