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

NCT07240701 | Not Yet Recruiting Phase 4

• 1 other identifier: 25-AKD-210
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

sepsis; Fluid Therapy; Saline Solution; Ringer's Lactate; Randomized Controlled Trial; Mortality; emergency department; Vasoconstrictor Agents; Renal Replacement Therapy; Crystalloid Solutions

Outcome Measures

Primary Outcomes (1)

• 24-hour All-Cause Mortality

  The proportion of participants who die from any cause within 24 hours after receiving the assigned study fluid (Ringer's lactate or normal saline) for initial resuscitation. Mortality will be determined based on hospital medical records.

  Within 24 hours after initiation of fluid resuscitation

Secondary Outcomes (7)

• Requirement for Vasopressor Support

  Within 6 hours after initiation of fluid resuscitation

• Requirement for Mechanical Ventilation

  Within 6 hours after initiation of fluid resuscitation

• Requirement for Emergency Hemodialysis

  Within 6 hours after initiation of fluid resuscitation

• Urine Output Response to Fluid Resuscitation

  Within 6 hours after initiation of fluid resuscitation

• Change in Serum Lactate Level

  Baseline and 3 hours after initiation of fluid resuscitation

Study Arms (2)

Ringer's Lactate Group

EXPERIMENTAL

Eligible participants in this group will receive Ringer's lactate solution as the initial intravenous fluid for resuscitating sepsis. This will be administered through a peripheral intravenous line at a rate of 1000 ml over 30-60 minutes, as determined by the attending physician and the patient's clinical condition. All other treatments will follow standard sepsis care protocols.

Other: Ringer's Lactate

Normal Saline Group

ACTIVE COMPARATOR

Eligible participants in this arm will receive 0.9% sodium chloride (normal saline) as the initial intravenous fluid for resuscitation in sepsis. This will be administered through a peripheral intravenous line at a rate of 1000 ml over 30-60 minutes, as determined by the attending physician and the patient's clinical condition. All other treatments will follow standard sepsis care protocols.

Other: Normal Saline (0.9% Sodium Chloride)

Interventions

Ringer's Lactate OTHER

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.

Ringer's Lactate Group

Normal Saline (0.9% Sodium Chloride) OTHER

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.

Normal Saline Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Known hypersensitivity to sodium lactate.
• Extracellular hyperhydration or hypervolemia.
• Severe renal failure with oliguria or anuria.

Sponsors & Collaborators

• Egemen Yildiz: lead

Study Sites (1)

Kutahya City Hospital

Kütahya, 43100, Turkey (Türkiye)

Location

Related Publications (1)

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.

  PMID: 34599691 BACKGROUND

MeSH Terms

Conditions

Sepsis; Emergencies

Interventions

Ringer's Lactate; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Egemen Yildiz, MD

CONTACT

+90 (274) 229 14 00; egemen.yildiz94@gmail.com

Ertan Sonmez, MD, Professor

CONTACT

+90 (274) 229 14 00; ertan.sonmez@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: Two parallel groups receive either Ringer's lactate or 0.9% sodium chloride (normal saline) for initial fluid resuscitation in sepsis, with double-blind randomization.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 21, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified individual participant data (IPD) and supporting documents will be available beginning 6 months after publication of the main results and will remain available for 5 years thereafter. Requests received after this period will be evaluated on a case-by-case basis.
• Access Criteria: Data will be shared with qualified researchers upon reasonable request. Interested investigators must submit a brief research proposal describing study aims, statistical analysis plan, and data protection procedures. Access will be granted after approval by the institutional ethics committee. The de-identified dataset and relevant documents will be shared electronically via a secure data transfer platform.

Locations

TU (1)