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A simple choice of IV fluid during surgery could change outcomes — which is safer?

NCT ID NCT02502773

Disease control Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests two types of intravenous fluids given during abdominal surgery: a standard saline solution and a starch-based fluid. The goal is to see whether one leads to fewer serious complications, such as kidney problems, breathing issues, heart failure, infections, or the need for another surgery, within the first two weeks after the operation. The study includes adults at moderate-to-high risk of complications who are having abdominal surgery lasting at least two hours. By comparing these fluids in a controlled way, the trial aims to find out if the choice of fluid can improve patient safety and recovery.

What this could mean

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

Active substance
Hydroxyethyl starch (6% HES 130/0.4) compared with 0.9% saline, given as intravenous fluid during surgery
What this could lead to
If one fluid is better, it could guide safer fluid management during major abdominal surgery, potentially reducing serious complications and deaths after surgery.
What could go wrong
This is a phase 3 trial, but results may not apply to all patients or surgeries. Hydroxyethyl starch carries risks like kidney injury and bleeding, which the trial is specifically checking.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

826 people

The number who actually took part.

Started

Feb 2016

Finished

Oct 2018

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: All adult patients who * Undergo elective or emergency abdominal surgery under general anesthesia * With an estimated surgical duration greater than or equal to 2 hours * With moderate-to-high risk of postoperative complications defined by an AKI risk index≥ class 3, as defined by the presence of at least 4 of the following factors: age\> 56 years, male gender, intraperitoneal surgery, active congestive heart failure, ascites, hypertension, emergency surgery, mild or moderate renal insufficiency, diabetes mellitus treated by oral or insulin therapy Exclusion Criteria: The following patients will not be evaluated for inclusion: * Age \<18 years * Preoperative acute heart failure * Preoperative acute coronary insufficiency * Preoperative severe renal failure (defined by creatinine clearance \<30 ml/min or requiring renal replacement therapy) * Preoperative shock defined by the need for vasoactive amines * History of allergy with the use of 6% Hydroxethyl starch 130/0.4 * Contraindication to the use of HES: sepsis, burnt patient, renal insufficiency or dialysis, cerebral hemorrhage, ICU patient , hypervolemia, lung edema, dehydration, severe hypernatremia or severe hyperchloremia, severe hepatic insufficiency, congestive heart failure, severe coagulopathy, organ transplant * Patient's or relative's refusal to participate * Parturient or breastfeeding woman * Protected major (guardianship)

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As listed by the trial registrant

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

Postoperative morbidity Postoperative mortality

Contacts and locations

Locations

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France

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