Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a common steroid shield surgery patients from sepsis and lung failure?

NCT ID NCT03218553

Prevention Sponsor: Nantes University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Major non-cardiac surgery triggers a strong inflammatory response that can lead to sepsis, lung failure, and death. Researchers are testing whether two intravenous doses of dexamethasone, a steroid, given at the end of surgery and 24 hours later can dampen that response and reduce these complications. The trial enrolls about 1,200 adults over 50 with added heart or lung risks, or over 65, undergoing major abdominal, pelvic, chest, neck, or vascular surgery. It compares dexamethasone with placebo to see whether the steroid lowers the combined rate of sepsis, lung complications, and death.

What this could mean

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

Active substance
dexamethasone, a steroid given as two intravenous doses around surgery
What this could lead to
If it works, a cheap, widely available steroid could become a routine step to prevent serious complications after major non-cardiac surgery.
What could go wrong
Earlier trials of steroids in surgery gave mixed results, and steroids can raise blood sugar and may increase infection risk. The trial may show no benefit or unexpected harm.

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

1,222 people

The number who actually took part.

Started

Dec 2017

Finished

Apr 2019

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 to 90 years

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: Major surgery (\> 90 minutes and realized under general anesthesia) of the abdomen, pelvis, thorax, face/neck, vascular surgery in a patient older than 65 years Or Major surgery (\> 90 minutes and realized under general anesthesia) of the abdomen, pelvis, thorax, face/neck, vascular surgery in a patient older than 50 years and presenting one of the following criteria * Presence of a defined risk factor for cardiac or respiratory disease (exercise tolerance equivalent to 6 metabolic equivalents or less) * Medical history of stroke * Moderate to severe renal impairment (clearance of creatinine ≤ 30 mll/L) * Active smoking * Averaged observed blood losses over 500 ml * Emergency surgery Exclusion Criteria: * Pregnant women, Minors, Adults under guardianship or trusteeship * Treatment with systemic corticosteroids at a dose \> 5 mg.day-1 of equivalent prednisolone in the previous 3 months * Patients with chronic renal failure (clearance of creatinine \< 10 ml/min) * Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 1 month * Patient with preoperative shock (defined by the need for vasoactive drugs before surgery) * Acute Pulmonary edema in the last 7 days * Active bacterial or viral infection * Allergy to the intravenous formulation of dexamethasone * Uncontrolled psychotic disorder (acute or chronical)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Major non-cardiac surgery are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

As listed by the trial registrant

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

Major non-cardiac surgery

Contacts and locations

Locations

  • C.R.L.C.C. Nantes Atlantique

    Nantes, 44805, France

  • CH Valenciennes

    Valenciennes, 59300, France

  • CHD Vendée

    La Roche-sur-Yon, 85000, France

  • CHU Angers

    Angers, 49933, France

  • CHU La Cavale Blanche

    Brest, 29609, France

  • CHU Lyon Sud

    Pierre-Bénite, 69310, France

  • CHU Saint Etienne

    Saint-Etienne, 42055, France

  • CHU de Poitiers

    Poitiers, 86021, France

  • CHU de Rouen

    Rouen, 76031, France

  • CHU de Toulouse

    Toulouse, 31059, France

  • Centre Hospitalier Du Mans

    Le Mans, 72037, France

  • Ch Quimper

    Quimper, 29107, France

  • Clinique Jules Verne

    Nantes, 44000, France

  • Hopital Edouard Herriot

    Lyon, 69003, France

  • Hotel Dieu Nantes

    Nantes, 44093, France

  • Hôpital Beaujon

    Clichy, 92110, France

  • Hôpital Claude Huriez

    Lille, 59037, France

  • Hôpital Estaing, CHU de Clermont Ferrand

    Clermont-Ferrand, 63000, France

  • Hôpital Laennec

    Nantes, 44093, France

  • Hôpital Nord

    Marseille, 13975, France

  • Hôpital Pontchaillou

    Rennes, 35033, France

  • Hôpital Saint Antoine

    Paris, 75000, France

  • Hôpital Saint-Eloi

    Montpellier, 34295, France

  • Hôpital Timone

    Marseille, 13385, France

  • Hôpitaux Universitaires Saint-Louis, Lariboisière, Fernand Widal

    Paris, 75475, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Le Confluent

    Nantes, 44000, France

  • Nouvel Hôpital Civil

    Strasbourg, 67098, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.