Could a simple infusion during surgery protect organs and save lives?
NCT ID NCT01536470
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial tests whether giving a continuous infusion of noradrenaline during high-risk surgery can prevent dangerous drops in blood pressure, compared to the standard approach of treating low blood pressure only when it occurs. The study includes 300 adults aged 50 and older undergoing major abdominal, orthopedic, or vascular surgery expected to last at least two hours. The goal is to see if this preventive strategy reduces the chance of postoperative organ failure and other serious complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- noradrenaline (also called norepinephrine), given as a continuous infusion to maintain blood pressure during surgery
- What this could lead to
- If effective, this approach could reduce organ failure after major surgery, improving recovery and reducing complications in high-risk patients.
- What could go wrong
- The trial is relatively small and focuses on a specific high-risk group, so results may not apply to all surgeries. Noradrenaline can cause high blood pressure or heart rhythm issues, and the benefit over standard care is not yet proven.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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300 people
The number who actually took part.
- Start date
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Mar 2012
- Finished
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Jul 2016
- Lead sponsor
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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
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 ≥ 50 years * ASA score ≥ 2 * Planned and unplanned surgical procedures * Abdominal, orthopaedic and vascular surgery * Expected duration ≥ 2 hours * AKI risk index ≥ class 3 Exclusion Criteria: * Severe preoperative hypertension (not controlled) * Creatinine clearance \< 30 ml/min or preoperative dialysis * Acute cardiac failure * Preoperative sepsis * Preoperative hemodynamic failure (shock) * Intraoperative use of locoregional anaesthesia (epidural and spinal) * Patient refusal * Pregnancy and/or lactation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France