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Coronary; IschemicOPTI-AGEDNCT02668250

Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality

A study testing OPTI-AGED in people with Coronary; Ischemic and Arrhythmias, Cardiac, run by Centre Hospitalier Universitaire de Saint Etienne at 29 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

With the increasing aging population demographics and life expectancies, the number of very elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group. Read more about this study

Who is it for?
Ages 75 years and older
What is being tested?
OPTI-AGED
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,495 participants
Where
29 sitesFrance
Study dates
3 Feb 2017to 16 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • All adult patients aged 75 years and over,
  • presenting at least one of the following comorbidities: ischemic coronary disease; cardiac arrhythmia; congestive heart failure; peripheral vascular disease; dementia; stroke; chronic obstructive pulmonary disease; chronic respiratory failure; chronic alcohol abuse; active cancer; diabetes; chronic renal failure A comorbidity index will be measured by using the modified Charlson Comorbidity Index
  • undergoing elective and emergency surgeries including : femoral head fracture, major intraperitoneal abdominal surgery lasting > 90 min (excluding elective cholecystectomy, abdominal wall surgery), vascular surgery (excluding venous surgery and fistula creation)
  • Patient's or patient's relative signed consent form
  • Affiliation to French social assurance system

Who cannot join

  • Acute heart failure and acute coronary syndrome
  • Acute respiratory failure, pneumonia
  • Septic shock
  • Delirium
  • Acute stroke
  • Evolutive neuromuscular disorder
Show all 10Show fewer
  • Thoracic surgery, combined abdominal and thoracic surgery
  • Surgery performed under exclusive regional anesthesia
  • Patients under tutorship or curatorship
  • Refusal to participate

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

France29 sites

  • CHU Amiens - Picardie

    Amiens

  • CHU CAEN

    Caen

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63003

  • Médipôle Lyon - Villeurbanne

    Décines-Charpieu

  • Chu Dijon

    Dijon, 21079

  • Chu Grenoble

    Grenoble, 38043

  • CHRU Lille - Salengro

    Lille, 59000

  • CHU LILLE - Huriez

    Lille, 59037

  • CHU LYON

    Lyon

  • Lyon Sud - CHU

    Lyon

  • Chu Marseille La Timone

    Marseille, 13385

  • Chu Marseille Nord

    Marseille, 13385

  • Chu Montpellier

    Montpellier, 34295

  • Chu Nancy

    Nancy, 54035

  • CHU de Nantes

    Nantes

  • CHU NICE

    Nice

  • Chu Nimes

    Nîmes

  • Ch Paris Beaujon

    Paris

  • Ch Paris Bichat

    Paris

  • Ch Paris Pitie Salpetriere

    Paris

  • Ch Paris Saint Antoine

    Paris

  • Ch Saint Louis-Lariboisiere

    Paris

  • Chu Poitiers

    Poitiers, 86021

  • Chu Rennes

    Rennes

  • Chu Rouen

    Rouen, 76031

  • Chu Saint Etienne

    Saint-Etienne, 42100

  • Hopital Central Strasbourg

    Strasbourg, 67098

  • Hopital Hautepierre Strasbourg

    Strasbourg, 67098

  • Chu Toulouse

    Toulouse, 31059

Other trials in France

About this study

Official title: The OPTI-AGED Study : Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality in Elderly Patients. A Randomized, Multicentre, Prospective Controlled Study

With the increasing aging population demographics and life expectancies, the number of very elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group.

Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes.

Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.

Read the detailed description

The population is expanding and aging. With the increasing aging population demographics and life expectancies, the number of very elderly patients (age ≥ 75) undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group. In 2010, patients aged 75 yrs and over represented only 2.1% of patients undergoing high risk surgery in France (PMSI database), but concentrated 27% of in-hospital deaths.

Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes. Meta-analyses have demonstrated that goal directed hemodynamic therapy significantly reduced mortality and surgical complications in high-risk patients. A lung-protective ventilation strategy in high-risk patients undergoing major abdominal surgery was associated with improved clinical outcome. Retrospective studies indicated that a combination of excessive depth of anesthesia, hypotension and low anesthesia requirement resulted in increased mortality. These approaches of peroperative care remain discussed in the literature and have also to be incorporated in the common clinical practice. Moreover, few of these reviews performed a sensitive analysis in the elderly.

Whether a multi-parametric optimization strategy of anesthesia including several specific interventions will impact the short-term postoperative major morbidity and mortality in elderly is not known. The addition of depth of anesthesia monitoring to hemodynamic monitoring and goal directed hemodynamic therapy may improve tissue perfusion by reducing hemodynamic side effects of anesthetic agents, particularly in elderly where the therapeutic window of these agents is reduced. The effects of low protective ventilation may also by additive to the previous measures by reducing the perioperative build-up of oxygen debt. Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.

Being tested
OPTI-AGED, Usual Care
Medical subject headings
Ischemia, Arrhythmias, Cardiac, Heart Failure, Peripheral Vascular Diseases, Dementia, Stroke, Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OPTI-AGEDProcedure or surgery

    OPTI-AGED is composed of a multi-parametric optimization strategy.

  • Usual CareProcedure or surgery

    Patients receive the usual care.

Study groups in NCT02668250
Study groupRoleWhat they receive
Experimental group : OPTI-AGEDExperimentalThe OPTI-AGED group will receive a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia.
Receives: Procedure: OPTI-AGED
Control Group :Active comparatorThe control group will not benefit from the OPTI-AGED intervention but patients will receive the usual care.
Receives: Procedure: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of a composite of mortality or major postoperative morbidity.

    One or more of major postoperative complications : acute kidney injury (defined by Kidney disease : improving Global Outcomes (KDIGO) stage 1 or higher), acute myocardial infarction, heart failure, stroke, development of sepsisand septic shock, acute respiratory failure requiring non-invasive ventilation or intubation, delirium) will be reported in the source folder of the patients, and the mortality will be also focused. The goal of this study is to decrease this incidence.

    Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2016 (estimated)
  2. Study start3 Feb 2017
  3. Primary completion5 Feb 2020
  4. Study completion16 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,495 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02668250
Sponsor's protocol ID
1508190
Other IDs
ANSM
Acronym
OPTI-AGED
Status last verified
Aug 2021
First submitted
22 Jan 2016
Last updated
26 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Molliex S, Passot S, Futier E, Bonnefoi M, Rancon F, Lemanach Y, Pereira B. Stepped wedge cluster randomised controlled trial to assess the effectiveness of an optimisation strategy for general anaesthesia on postoperative morbidity and mortality in elderly patients (the OPTI-AGED study): a study protocol. BMJ Open. 2018 Jun 19;8(6):e021053. doi: 10.1136/bmjopen-2017-021053.

    PubMed 29921685

Questions about this trial

What is this clinical trial studying?

A study testing OPTI-AGED in people with Coronary; Ischemic and Arrhythmias, Cardiac, run by Centre Hospitalier Universitaire de Saint Etienne at 29 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of a composite of mortality or major postoperative morbidity. (time frame: Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02668250, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.

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