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New monitoring method may cut surgery risks by guiding fluid use

NCT ID NCT03828565

Disease control Sponsor: Assistance Publique Hopitaux De Marseille 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether continuously monitoring central venous oxygen saturation (ScvO2) during major abdominal surgery helps doctors give fluids more precisely, reducing complications. 220 patients over 50 with moderate-to-high surgical risk were randomly assigned to ScvO2-guided care or standard care. The goal was to see if this approach lowers the overall complication score at day 5 after surgery.

What this could mean

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

Active substance
ScvO2 continuous monitoring with PreSep® system
What this could lead to
If successful, this approach could reduce post-surgery complications by better guiding fluid therapy during major abdominal surgeries.
What could go wrong
This is a completed trial with 220 participants, but the intervention is a monitoring procedure, not a drug, so benefits may be modest and context-dependent.

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

220 people

The number who actually took part.

Started

Mar 2019

Finished

Sep 2023

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

50 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: * \>50 years old * ASA score ≥ 2 * requiring a major intra-abdominal scheduled surgery * lasting more than 90 min * in the visceral surgery, vascular surgery, urological surgery and gynecological surgery sectors Exclusion Criteria: * \<18 years old * Pregnant or brest feeding patients * no consentement * Unstable acute pathology at the time of surgery (acute heart, respiratory or renal failure, severe sepsis or septic shock, hemorrhagic shock); * rhythm disorders type ACFA early intervention; * Palliative surgery, ASA 5; * Patient under guardianship or curatorship.

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As listed by the trial registrant

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

Cardiac flow

Contacts and locations

Locations

  • Laurent Zieleskiewicz

    Marseille, PACA, 13354, France