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NCT07240701

PHASE4

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

Sponsor: Egemen Yildiz

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-11

Completion Date

2026-11

Last Updated

2025-11-21

Healthy Volunteers

Conditions

Sepsis

Interventions

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.

Inclusion Criteria: * Adult male or female patients (≥18 years of age) presenting to the emergency department. * Diagnosed or suspected sepsis secondary to an infectious cause. * Provision of written informed consent by the patient, or if the patient is unable to consent, by a first-degree relative or legally authorized representative. Exclusion Criteria: * Age under 18 years old. * Pregnant women. * Informed consent was not obtained from the patient or their first-degree relative/legal guardian. * Patients who are receiving cardiopulmonary resuscitation (CPR) or who require endotracheal intubation at the time of presentation. * Patients with severe volume depletion unrelated to sepsis (e.g., diabetic ketoacidosis, burns, or active gastrointestinal bleeding). * Patients with severe hyperkalemia (serum potassium level of at least 6.5 mmol/L with ECG changes). * Patients with hypotension that is not related to sepsis (e.g., active hemorrhage or intracranial bleeding). * Patients with clinical signs of pulmonary edema or congestive heart failure. * Cases in which the treating physician determines that one isotonic crystalloid (Ringer's lactate or 0.9% NaCl) is clearly superior to the other due to clinical condition or comorbidities. * Cases in which the treating physician anticipates that fluid therapy might be delayed due to study participation. * Patients requiring immediate hospital or ICU admission before completion of initial emergency department resuscitation. * Patients with sepsis sources requiring urgent invasive intervention known to directly affect mortality (e.g., an undrainable abscess or osteomyelitis). Additional exclusion criteria based on the contraindications listed in the Ringer's lactate product information:, * Known hypersensitivity to sodium lactate. * Extracellular hyperhydration or hypervolemia. * Severe renal failure with oliguria or anuria. * Decompensated heart failure. * Hypercalcemia. * Metabolic alkalosis or severe metabolic acidosis. * Conditions associated with impaired lactate metabolism, such as lactic acidosis, severe liver failure, and cirrhosis with ascites. * Current use of digitalis preparations (e.g., digoxin).

Locations (1)

Kutahya City Hospital

Kütahya, Turkey (Türkiye)