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A standard IV fluid dose may reveal who is at risk after bowel surgery

NCT ID NCT07823530

Diagnosis Sponsor: University Hospital of Split 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers at University Hospital of Split are studying whether short-term changes in body-impedance readings after a standard intravenous fluid infusion can help predict complications after elective colon or rectal surgery. About 120 adults scheduled for these operations will receive Ionolyte, a balanced salt solution, at a set dose over 40 minutes. The team measures body composition before and after the infusion and tracks whether participants develop complications within 30 days. A separate comparison looks at past hospital records of 240 similar patients who did not receive the study procedure.

What this could mean

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

Active substance
Ionolyte, a balanced isotonic crystalloid fluid given intravenously before surgery
What this could lead to
If the impedance shift tracks with complications, doctors could one day use a quick bedside fluid test to spot patients at higher risk before colon or rectal surgery.
What could go wrong
This is a single-center observational study, so it can show a link but not prove cause. The impedance change may not predict complications well enough to guide care, and results may not hold at other hospitals.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2033

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 or older * Scheduled for elective colon or rectal resection at University Hospital of Split * Written informed consent before research-specific procedures * Able to stand safely and complete both BIA measurements * Preoperative eGFR at least 60 mL/min/1.73 m² * Clinically eligible for the protocol fluid volume Exclusion Criteria: * Emergency surgery * eGFR below 60 mL/min/1.73 m² or oliguria * Heart failure or clinically significant cardiac disease making fluid loading inappropriate * Edema, pulmonary congestion, or clinically significant ascites * Active implantable electrical device * Limb amputation, inability to undergo standardized standing BIA, or unsafe standing * Clinically significant electrolyte abnormality * Pregnancy * Contraindication to Ionolyte or any clinician safety concern * Inability to provide valid informed consent

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Conditions

The condition(s) this trial relates to.

Postoperative Complications

As listed by the trial registrant

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

Postoperative complications

How to take part

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  1. The places running it

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  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

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Contacts and locations

Locations

  • University Hospital of Split, Department of Surgery

    Split, Split-Dalmatia County, 21000, Croatia

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