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New fluid strategy could save lives in emergency sepsis surgery

NCT ID NCT07172451

Disease control Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a balanced gelatin solution is safer and more effective than standard fluids for sepsis patients undergoing emergency abdominal surgery. Sepsis causes fluid loss, leading to low blood pressure and organ damage. The trial will enroll 318 adults and compare fluid balance, blood pressure stability, and kidney function between the two fluids. Results could guide better fluid management in this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Balanced gelatin solution (a type of fluid given intravenously to help maintain blood volume)
What this could lead to
If successful, this could show that balanced gelatin is a better fluid for stabilizing blood pressure and reducing fluid overload in septic patients during and after emergency abdominal surgery.
What could go wrong
This is a relatively small, early-phase trial (phase 4) and results may not apply to all sepsis patients. There are also known risks with gelatin solutions, including potential allergic reactions and kidney injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 318 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years. * Diagnosis of sepsis according to the Sepsis-3 definition, caused by intra-abdominal infection, and requiring emergency abdominal surgery for source control. * Sequential Organ Failure Assessment (SOFA-2) score ≥ 2 (determined by the most recent available clinical data) and blood lactate \> 2 mmol/L (measured within 6 hours prior to enrollment). * Subject or legal representative can understand the study purpose and provide written informed consent. Exclusion Criteria: * Received any dose of artificial colloids within 24 hours prior to randomization. * Predicted mortality within 48 hours (ASA physical status class ≥ V). * Atrial fibrillation or congestive heart failure. * Severe Acute Respiratory Distress Syndrome (ARDS). * Preoperative coagulation dysfunction or receiving anticoagulant therapy. * Preoperative requirement for renal replacement therapy (long-term or intermittent, including hemodialysis or peritoneal dialysis). * Acute burns exceeding 10% of the total body surface area. * Severe hepatic impairment. * Severe electrolyte disturbance. * Pregnancy or breastfeeding. * Known allergy to gelatin. * Current participation in other interventional clinical trials. * Other conditions that the investigator considers inappropriate for inclusion.

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Intraabdominal Infections Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intra abdominal infections Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Xuzhou Medical University

    NOT_YET_RECRUITING

    Xuzhou, Jiangsu, 221000, China

  • The First Affiliated Hospital of Soochow University

    NOT_YET_RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital, Sun Yat-sen University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510080, China

  • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University (WMU)

    NOT_YET_RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310058, China

  • Tianjin Medical University General Hospital

    NOT_YET_RECRUITING

    Tianjing, Tianjing, 300052, China

  • West China Hospital of Sichuan University

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610041, China

  • Zhongda Hospital, Southeast University

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210009, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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