Sepsis
Conditions
Keywords
sepsis, Fluid Therapy, Saline Solution, Ringer's Lactate, Randomized Controlled Trial, Mortality, emergency department, Vasoconstrictor Agents, Renal Replacement Therapy, Crystalloid Solutions
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.
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.
Interventions
OTHERRinger'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.
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.
Sponsors
Egemen Yildiz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour All-Cause Mortality | Within 24 hours after initiation of fluid resuscitation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Requirement for Mechanical Ventilation | Within 6 hours after initiation of fluid resuscitation | The proportion of participants who require endotracheal intubation and mechanical ventilation within six hours of the initial administration of fluids. Will be reported as a percentage. |
| Requirement for Emergency Hemodialysis | Within 6 hours after initiation of fluid resuscitation | The proportion of participants who require emergency hemodialysis within 6 hours after initial fluid administration. The outcome will be reported as a percentage. |
| Urine Output Response to Fluid Resuscitation | Within 6 hours after initiation of fluid resuscitation | The proportion of participants with a total urine output of ≥3 mL/kg during the first six hours after receiving the study fluid, as recorded in the patient's follow-up chart. The outcome will be reported as a percentage. |
| Requirement for Vasopressor Support | Within 6 hours after initiation of fluid resuscitation | The proportion of participants who receive any vasopressor agents (e.g. norepinephrine, epinephrine or vasopressin) within six hours of initial fluid administration, as documented in the medical record. Will be reported as a percentage. |
| Length of Stay in Intensive Care Unit (ICU) | From ICU admission until ICU discharge, assessed up to 30 days | Duration of ICU stay, measured in days among participants admitted to the ICU after initial fluid resuscitation. |
| Total Length of Hospital Stay | From hospital admission until hospital discharge, assessed up to 30 days | Total duration of hospitalization, measured in days based on hospital records. |
| Change in Serum Lactate Level | Baseline and 3 hours after initiation of fluid resuscitation | Change in serum lactate concentration (mmol/L), calculated as the difference between the value at 3 hours and the baseline value obtained before fluid administration. The outcome will be reported as the mean change (mmol/L). |
Countries
Turkey (Türkiye)
Contacts
Primary ContactEgemen Yildiz, MD
Backup ContactErtan Sonmez, MD, Professor
Outcome results
None listed