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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Requirement for Vasopressor Support | 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. | Within 6 hours after initiation of fluid resuscitation |
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Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria based on the contraindications listed in the Ringer's lactate product information:,
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kutahya City Hospital | Kütahya | 43100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34599691 | Background | 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. |
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De-identified individual participant data (IPD) underlying the study results will be shared upon reasonable request after publication. Shared data will include demographic, treatment, and outcome variables. Access will be granted to qualified researchers with ethics committee approval and a sound research proposal.
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.
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.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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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.
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|
| 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. |
|
| Requirement for Mechanical Ventilation |
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. |
| Within 6 hours after initiation of fluid resuscitation |
| Requirement for Emergency Hemodialysis | The proportion of participants who require emergency hemodialysis within 6 hours after initial fluid administration. The outcome will be reported as a percentage. | Within 6 hours after initiation of fluid resuscitation |
| Urine Output Response to 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. | Within 6 hours after initiation of fluid resuscitation |
| Change in Serum Lactate Level | 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). | Baseline and 3 hours after initiation of fluid resuscitation |
| Length of Stay in Intensive Care Unit (ICU) | Duration of ICU stay, measured in days among participants admitted to the ICU after initial fluid resuscitation. | From ICU admission until ICU discharge, assessed up to 30 days |
| Total Length of Hospital Stay | Total duration of hospitalization, measured in days based on hospital records. | From hospital admission until hospital discharge, assessed up to 30 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |