Major Non-cardiac SurgeryPhase 3PACMANNCT03218553
Effects of Perioperative Administration of Dexamethasone on Postoperative Complications and Mortality After Non-cardiac Major Surgery
A Phase 3 study testing Dexamethasone in people with Major Non-cardiac Surgery, run by Nantes University Hospital at 29 sites in France.
Trial summary
Postoperative complications are major healthcare problems and are associated with a reduced short-term and long-term survival after surgery. Major surgery is associated with a predictable and usually transient Systemic Inflammatory Response (SIRS), depending on the magnitude of the surgical trauma. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Major Non-cardiac Surgery
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,222 participants
- Where
- 29 sitesFrance
- Study dates
- 13 Dec 2017to 16 Apr 2019
- Phase
- Phase 3
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Active bacterial or viral infection
- Allergy to the intravenous formulation of dexamethasone
- Uncontrolled psychotic disorder (acute or chronical)
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
France29 sites
CHU Angers
Angers, 49933
CHU La Cavale Blanche
Brest, 29609
Hôpital Estaing, CHU de Clermont Ferrand
Clermont-Ferrand, 63000
Hôpital Beaujon
Clichy, 92110
CHD Vendée
La Roche-sur-Yon, 85000
Centre Hospitalier Du Mans
Le Mans, 72037
Hôpital Claude Huriez
Lille, 59037
Hopital Edouard Herriot
Lyon, 69003
Institut Paoli Calmettes
Marseille, 13009
Hôpital Timone
Marseille, 13385
Hôpital Nord
Marseille, 13975
Hôpital Saint-Eloi
Montpellier, 34295
Clinique Jules Verne
Nantes, 44000
Le Confluent
Nantes, 44000
Hotel Dieu Nantes
Nantes, 44093
Hôpital Laennec
Nantes, 44093
C.R.L.C.C. Nantes Atlantique
Nantes, 44805
Hôpital Saint Antoine
Paris, 75000
Hôpitaux Universitaires Saint-Louis, Lariboisière, Fernand Widal
Paris, 75475
CHU Lyon Sud
Pierre-Bénite, 69310
CHU de Poitiers
Poitiers, 86021
Ch Quimper
Quimper, 29107
Hôpital Pontchaillou
Rennes, 35033
CHU de Rouen
Rouen, 76031
CHU Saint Etienne
Saint-Etienne, 42055
Nouvel Hôpital Civil
Strasbourg, 67098
CHU de Toulouse
Toulouse, 31059
CH Valenciennes
Valenciennes, 59300
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Effects of Perioperative Administration of Dexamethasone on Postoperative Complications and Mortality After Non-cardiac Major Surgery : a Randomized, Multicentre, Double Blind, Study
Postoperative complications are major healthcare problems and are associated with a reduced short-term and long-term survival after surgery. Major surgery is associated with a predictable and usually transient Systemic Inflammatory Response (SIRS), depending on the magnitude of the surgical trauma. An excessive SIRS syndrome participates to the development of postoperative organ dysfunction, infection and mortality. Corticosteroids may decrease the postsurgical SIRS in cardiac surgery: in a large multicenter randomized trial, a single intravenous administration of high-dose dexamethasone did not reduce the incidence of a composite endpoint of adverse events but was associated with a reduced incidence of postoperative pulmonary complications and infections and with a reduction in hospital stay. However, a similar study, recently published in the Lancet was negative. Evidences from one meta-analysis, including 11 studies of moderate quality (439 patients in total), suggest that intraoperative administration of corticosteroids during major abdominal surgery decreases postoperative complications, including infectious complications, without significant risk of anastomotic leakage. At present, no large randomized controlled trial has been performed in patients undergoing major non-cardiac surgery. In acute medicine, several lines of evidence have shown that low to moderate doses of corticosteroids decrease the excessive inflammatory response, without inducing immuno suppression. However, despite the widespread use of corticosteroids to reduce postoperative nausea and vomiting and to improve analgesia, concerns continue to be raised about their safety, especially regarding an increased risk of postoperative infection.
We hypothesize that the perioperative administration of glucocorticoids would reduce postoperative morbidity after major non-cardiac surgery through dampening of the inflammatory response. Given the number of surgical patients for whom the question applies, the study is of significant clinical importance
Read the detailed description
Background :
Postoperative complications are major healthcare problems and are associated with a reduced short-term and long-term survival after surgery. Corticosteroids may decrease the postsurgical SIRS in cardiac surgery, but this treatment is not recommended yet. The aim of the current study is to assess the efficiency and the safety of dexamethasone to prevent on postoperative complications.
Methods :
The PACMAN trial is a multicenter, randomized, controlled, double-blind, two-arms study. 1222 patients undergoing major surgery (duration >90 minutes and one or more risk factor of postoperative complication) are randomized to dexamethasone (0.2mg/kg at the end of the surgery and at day1) or to placebo. The primary outcome is a composite outcome of major postoperative complication during 14 days after the surgery.
Analyzes will be conducted, first, on data from the intention-to-treat (ITT) population, second, in the modified intention-to-treat (mITT) population as well as in the per-protocol population. All statistical analyzes will take into account stratified randomization (cancer and type of surgery) and will be adjusted on the center as random effect as.
Discussion :
The PACMAN trial is the first randomized controlled trial powered to investigate whether perioperative administration of dexamethasone in high risk patients improve outcomes.
- Conditions
- Major Non-cardiac Surgery
- Being tested
- Dexamethasone, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone : first dose : 0,2mg.kg-1 at the end of the surgical procedure, second dose (0,2 mg.kg-1) 24 hours after the surgery
PlacebosDrug
placebo : first infusion at the end of the surgical procedure, second 24 hours after the surgery
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Standard cares plus postoperative administrations of glucocorticoid Receives: Drug: Dexamethasone |
| placebo | Placebo comparator | Standard cares plus postoperative administrations of placebo Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome at least one item among the following:-Postoperative sepsis, severe sepsis, septic shock-Postoperative pulmonary complication: pneumonia, need for invasive and/or noninvasive ventilation for respiratory failure-All-cause mortality
Measured: 14 days
Secondary outcomes (20)
All cause mortality
Measured: 28 days
Hospital free days
Measured: 28 days
Rate of patients with post operative sepsis
Measured: 28 days
Postoperative intubation rate for respiratory failure
Postoperative respiratory failure requiring invasive ventilation
Measured: 28 days
Rate of patients with postoperative respiratory failure requiring non-invasive ventilation
Measured: 28 days
Surgical complications
The Clavien-Dindo classification
Measured: 28 days
Duration of hospitalization
Measured: 28 days
Rate of unplanned hospitalization in intensive care unit
Measured: 28 days
Rate of patients developing postoperative organ failures
Measured: 28 days
Blood level of marker of inflammation (C Reactive protein)
Measured: 28 days
Delayed healing defined as non hermetic scar
Measured: 28 days
ICU length of stay
Measured: 28 days
Rate of patients with Gastric ulcer
Measured: 28 days
Rate of patients with Digestive bleeding
Measured: 28 days
Rate of patients with Anastomotic leakage
Measured: 28 days
Dose of insulin
Measured: 3 days
Rate of patients with Hypokaliemia (< 4 mmol/l)
Measured: 28 days
Rate of patients with Dysnatremia (<139 mmol/l or > 145 mmol/l)
Measured: 28 days
Rate of patients with Hypocalcemia (<2.2 mmol/l)
Measured: 28 days
Rate of patients with Cardiac events (Atrial fibrillation / cardiac flutter, Acute coronary syndrome or Cardiac failure)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start13 Dec 2017
- Primary completion16 Apr 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Non-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218553
- Sponsor's protocol ID
- RC17_0029
- Acronym
- PACMAN
- Status last verified
- May 2020
- First submitted
- 10 Jul 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asehnoune K, Le Moal C, Lebuffe G, Le Penndu M, Josse NC, Boisson M, Lescot T, Faucher M, Jaber S, Godet T, Leone M, Motamed C, David JS, Cinotti R, El Amine Y, Liutkus D, Garot M, Marc A, Le Corre A, Thomasseau A, Jobert A, Flet L, Feuillet F, Pere M, Futier E, Roquilly A; PACMAN study group. Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial. BMJ. 2021 Jun 2;373:n1162. doi: 10.1136/bmj.n1162.
PubMed 34078591Asehnoune K, Futier E, Feuillet F, Roquilly A; PACMAN group. PACMAN trial protocol, Perioperative Administration of Corticotherapy on Morbidity and mortality After Non-cardiac major surgery: a randomised, multicentre, double-blind, superiority study. BMJ Open. 2019 Mar 23;9(3):e021262. doi: 10.1136/bmjopen-2017-021262.
PubMed 30904834
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perioperative Administration of Dexamethasone on Postoperative Complications and Mortality After Non-cardiac Major Surgery : a Randomized, Multicentre, Double Blind, Study
- ClinicalTrials.gov ID
- NCT03218553
- Acronym / sponsor ID
- PACMAN / RC17_0029
- Conditions
- Major Non-cardiac Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,222 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative complications are major healthcare problems and are associated with a reduced short-term and long-term survival after surgery. Major surgery is associated with a predictable and usually transient Systemic Inflammatory Response (SIRS), depending on the magnitude of the surgical trauma. An excessive SIRS syndrome participates to the development of postoperative organ dysfunction, infection and mortality. Corticosteroids may decrease the postsurgical SIRS in cardiac surgery: in a large multicenter randomized trial, a single intravenous administration of high-dose dexamethasone did not reduce the incidence of a composite endpoint of adverse events but was associated with a reduced incidence of postoperative pulmonary complications and infections and with a reduction in hospital stay. However, a similar study, recently published in the Lancet was negative. Evidences from one meta-analysis, including 11 studies of moderate quality (439 patients in total), suggest that intraoperative administration of corticosteroids during major abdominal surgery decreases postoperative complications, including infectious complications, without significant risk of anastomotic leakage. At present, no large randomized controlled trial has been performed in patients undergoing major non-cardiac surgery. In acute medicine, several lines of evidence have shown that low to moderate doses of corticosteroids decrease the excessive inflammatory response, without inducing immuno suppression. However, despite the widespread use of corticosteroids to reduce postoperative nausea and vomiting and to improve analgesia, concerns continue to be raised about their safety, especially regarding an increased risk of postoperative infection.
We hypothesize that the perioperative administration of glucocorticoids would reduce postoperative morbidity after major non-cardiac surgery through dampening of the inflammatory response. Given the number of surgical patients for whom the question applies, the study is of significant clinical importance
Detailed description
Background :
Postoperative complications are major healthcare problems and are associated with a reduced short-term and long-term survival after surgery. Corticosteroids may decrease the postsurgical SIRS in cardiac surgery, but this treatment is not recommended yet. The aim of the current study is to assess the efficiency and the safety of dexamethasone to prevent on postoperative complications.
Methods :
The PACMAN trial is a multicenter, randomized, controlled, double-blind, two-arms study. 1222 patients undergoing major surgery (duration >90 minutes and one or more risk factor of postoperative complication) are randomized to dexamethasone (0.2mg/kg at the end of the surgery and at day1) or to placebo. The primary outcome is a composite outcome of major postoperative complication during 14 days after the surgery.
Analyzes will be conducted, first, on data from the intention-to-treat (ITT) population, second, in the modified intention-to-treat (mITT) population as well as in the per-protocol population. All statistical analyzes will take into account stratified randomization (cancer and type of surgery) and will be adjusted on the center as random effect as.
Discussion :
The PACMAN trial is the first randomized controlled trial powered to investigate whether perioperative administration of dexamethasone in high risk patients improve outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneStandard cares plus postoperative administrations of glucocorticoid |
| placebo | Placebo comparator | Drug: PlacebosStandard cares plus postoperative administrations of placebo |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneDexamethasone : first dose : 0,2mg.kg-1 at the end of the surgical procedure, second dose (0,2 mg.kg-1) 24 hours after the surgery | Drug | Dexamethasone |
| Placebosplacebo : first infusion at the end of the surgical procedure, second 24 hours after the surgery | Drug | placebo |
Primary outcome
Composite outcome at least one item among the following:-Postoperative sepsis, severe sepsis, septic shock-Postoperative pulmonary complication: pneumonia, need for invasive and/or noninvasive ventilation for respiratory failure-All-cause mortality
Time frame: 14 days
20 secondary outcomes
All cause mortality
Time frame: 28 days
Hospital free days
Time frame: 28 days
Rate of patients with post operative sepsis
Time frame: 28 days
Postoperative intubation rate for respiratory failure
Time frame: 28 days
Rate of patients with postoperative respiratory failure requiring non-invasive ventilation
Time frame: 28 days
Surgical complications
Time frame: 28 days
Duration of hospitalization
Time frame: 28 days
Rate of unplanned hospitalization in intensive care unit
Time frame: 28 days
Rate of patients developing postoperative organ failures
Time frame: 28 days
Blood level of marker of inflammation (C Reactive protein)
Time frame: 28 days
Delayed healing defined as non hermetic scar
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Rate of patients with Gastric ulcer
Time frame: 28 days
Rate of patients with Digestive bleeding
Time frame: 28 days
Rate of patients with Anastomotic leakage
Time frame: 28 days
Dose of insulin
Time frame: 3 days
Rate of patients with Hypokaliemia (< 4 mmol/l)
Time frame: 28 days
Rate of patients with Dysnatremia (<139 mmol/l or > 145 mmol/l)
Time frame: 28 days
Rate of patients with Hypocalcemia (<2.2 mmol/l)
Time frame: 28 days
Rate of patients with Cardiac events (Atrial fibrillation / cardiac flutter, Acute coronary syndrome or Cardiac failure)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 34078591Asehnoune K, Le Moal C, Lebuffe G, Le Penndu M, Josse NC, Boisson M, Lescot T, Faucher M, Jaber S, Godet T, Leone M, Motamed C, David JS, Cinotti R, El Amine Y, Liutkus D, Garot M, Marc A, Le Corre A, Thomasseau A, Jobert A, Flet L, Feuillet F, Pere M, Futier E, Roquilly A; PACMAN study group. Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial. BMJ. 2021 Jun 2;373:n1162. doi: 10.1136/bmj.n1162.
- Derived from this study: PubMed 30904834Asehnoune K, Futier E, Feuillet F, Roquilly A; PACMAN group. PACMAN trial protocol, Perioperative Administration of Corticotherapy on Morbidity and mortality After Non-cardiac major surgery: a randomised, multicentre, double-blind, superiority study. BMJ Open. 2019 Mar 23;9(3):e021262. doi: 10.1136/bmjopen-2017-021262.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone in people with Major Non-cardiac Surgery, run by Nantes University Hospital 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 7 inclusion and 9 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 14 Sep 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite outcome at least one item among the following:-Postoperative sepsis, severe sepsis, septic shock-Postoperative pulmonary complication: pneumonia, need for invasive and/or noninvasive ventilation for respiratory failure-All-cause mortality (time frame: 14 days). 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 NCT03218553, which also lists 2 linked publications.
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 14 Sep 2026.