SepsisPhase 4NCT07240701
Normal Saline Versus Ringer's Lactate for Initial Fluid Resuscitation in Sepsis
A Phase 4 study testing Ringer's Lactate and Normal Saline (0.9% Sodium Chloride) in people with Sepsis, run by Egemen Yildiz at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Ringer's Lactate and Normal Saline (0.9% Sodium Chloride)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2025to Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 21Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kutahya City Hospital
Kütahya, 43100
Egemen Yildiz, MD, + 90 (274) 229 14 00, egemen.yildiz94@gmail.com
Ertan Sonmez, MD, Professor, + 90 (274) 229 14 00, ertan.sonmez@ksbu.edu.tr
About this study
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
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:
Read more
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.
Read the 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
- Being tested
- Ringer's Lactate, Normal Saline (0.9% Sodium Chloride)
- Keywords
- sepsis, Fluid Therapy, Saline Solution, Ringer's Lactate, Randomized Controlled Trial, Mortality, emergency department, Vasoconstrictor Agents, Renal Replacement Therapy, Crystalloid Solutions
- Medical subject headings
- Sepsis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's LactateOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Normal Saline (0.9% Sodium Chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours after initiation of fluid resuscitation
Secondary outcomes (7)
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.
Measured: Within 6 hours after initiation of fluid resuscitation
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From hospital admission until hospital discharge, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egemen Yildiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Egemen Yildiz, Kutahya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240701
- Sponsor's protocol ID
- 25-AKD-210
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34599691
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07240701
- Acronym / sponsor ID
- 25-AKD-210
- Conditions
- Sepsis
- Keywords
- sepsis, Fluid Therapy, Saline Solution, Ringer's Lactate, Randomized Controlled Trial, Mortality, emergency department, Vasoconstrictor Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Egemen YildizUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ringer's Lactate Group | Experimental | Other: Ringer's LactateEligible 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 | Other: Normal Saline (0.9% Sodium Chloride)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ringer's LactateIntravenous 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 | Ringer's Lactate Group |
| 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. | Other | Normal Saline Group |
Primary outcome
24-hour All-Cause Mortality
Time frame: 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.
7 secondary outcomes
Requirement for Vasopressor Support
Time frame: Within 6 hours after initiation of fluid resuscitation
Requirement for Mechanical Ventilation
Time frame: Within 6 hours after initiation of fluid resuscitation
Requirement for Emergency Hemodialysis
Time frame: Within 6 hours after initiation of fluid resuscitation
Urine Output Response to Fluid Resuscitation
Time frame: Within 6 hours after initiation of fluid resuscitation
Change in Serum Lactate Level
Time frame: Baseline and 3 hours after initiation of fluid resuscitation
Length of Stay in Intensive Care Unit (ICU)
Time frame: From ICU admission until ICU discharge, assessed up to 30 days
Total Length of Hospital Stay
Time frame: From hospital admission until hospital discharge, assessed up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 34599691Evans 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ringer's Lactate and Normal Saline (0.9% Sodium Chloride) in people with Sepsis, run by Egemen Yildiz at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Egemen Yildiz, MD (+90 (274) 229 14 00, egemen.yildiz94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour All-Cause Mortality (time frame: Within 24 hours after initiation of fluid resuscitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.