Effects of perioperative administration of dexamethasone on postoperative complications and mortality after non-cardiac major surgery : a randomized, multicentre, double blind, study

Effects of perioperative administration of dexamethasone on postoperative complications and mortality after non-cardiac major surgery : a randomized, multicentre, double blind, study - PACMAN

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000442-21-FR

Enrollment

1222

Registered

2017-04-21

Start date

2017-09-12

Completion date

Unknown

Last updated

2020-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-cardiac major surgery MedDRA version: 20.0 Level: PT Classification code 10042609 Term: Surgery System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: DEXAMETHASONE MYLAN 20mg/5mL Product Name: DEXAMETHASONE Pharmaceutical Form: Solution for injection Trade Name: CHLORURE DE SODIUM LAVOISIER 0,9 POUR CENT Product Name: CHLORURE DE SODIU

Eligibility

Sex/Gender

All

Inclusion criteria

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 o Presence of a defined risk factor for cardiac or respiratory disease (exercise tolerance equivalent to 6 metabolic equivalents or less) o Medical history of stroke o Moderate to severe renal impairment (clearance of creatinine = 30 mll/L) o Active smoking o Averaged observed blood losses over 500 ml o Emergency surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the effectiveness of perioperative administration of corticosteroid to reduce postoperative morbidity and mortality in patients undergoing major non-cardiac surgery;Secondary Objective: - To evaluate the safety (clinical adverse events, especially glycaemic deregulation) of corticosteroids administration in patients undergoing major non-cardiac surgery - To evaluate the effect of corticosteroid administration on the incidence of postoperative infections, wound healing - To evaluate the effect of corticosteroid administration on postoperative gastrointestinal dysfunction - To evaluate the effect of corticosteroid administration on the duration of hospital stay ;Primary end point(s): Composite outcome (all-cause mortality and major postoperative complications) within 14 days after surgery, at least one item among the following: - Postoperative sepsis, severe sepsis, septic shock - Postoperative pulmonary complication (postoperative pneumonia, need for invasive ventilation and/or noninvasive ventilation for respiratory failure) ;Timepoint(s) of evaluation of this end point: 14 days after surgery	—

Measure

Time frame

Main Objective: Evaluate the effectiveness of perioperative administration of corticosteroid to reduce postoperative morbidity and mortality in patients undergoing major non-cardiac surgery;Secondary Objective: - To evaluate the safety (clinical adverse events, especially glycaemic deregulation) of corticosteroids administration in patients undergoing major non-cardiac surgery - To evaluate the effect of corticosteroid administration on the incidence of postoperative infections, wound healing - To evaluate the effect of corticosteroid administration on postoperative gastrointestinal dysfunction - To evaluate the effect of corticosteroid administration on the duration of hospital stay ;Primary end point(s): Composite outcome (all-cause mortality and major postoperative complications) within 14 days after surgery, at least one item among the following: - Postoperative sepsis, severe sepsis, septic shock - Postoperative pulmonary complication (postoperative pneumonia, need for invasive ventilation and/or noninvasive ventilation for respiratory failure) ;Timepoint(s) of evaluation of this end point: 14 days after surgery

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Secondary

Measure	Time frame
Secondary end point(s): - All-cause mortality 28 days after randomization - Hospital free-days at 28 days - Surgical complications according to the Clavien-Dindo classification within 28 days following randomization - Duration of hospital stay (patients who will be outside the hospital but in other types of health care facilities at day 28 will be considered to have been discharged home) - Unplanned admission or readmission to critical care (within 28 days following randomization) - Proportion of patients who experience postoperative morbidity (all defined according to consensus criteria or universal definitions within 7 days after surgery) including: o renal dysfunction (according to the KDIGO criteria: Appendix 2), o cardiac complications (acute heart failure, myocardial infarction), o infectious complications (especially surgical site infection), o gastrointestinal dysfunction - Duration of invasive mechanical ventilation, Duration of non-invasive mechanical ventilation - SOFA score at day 1 and day 3 after surgery - Percentage of patients with new organ dysfunction (not present at randomization) - Blood levels of CRP - Proportion of patients who experienced adverse events, especially hyperglycaemia, healing impairment within 7 days after surgery ;Timepoint(s) of evaluation of this end point: 28 days	—

Measure

Time frame

Secondary end point(s): - All-cause mortality 28 days after randomization - Hospital free-days at 28 days - Surgical complications according to the Clavien-Dindo classification within 28 days following randomization - Duration of hospital stay (patients who will be outside the hospital but in other types of health care facilities at day 28 will be considered to have been discharged home) - Unplanned admission or readmission to critical care (within 28 days following randomization) - Proportion of patients who experience postoperative morbidity (all defined according to consensus criteria or universal definitions within 7 days after surgery) including: o renal dysfunction (according to the KDIGO criteria: Appendix 2), o cardiac complications (acute heart failure, myocardial infarction), o infectious complications (especially surgical site infection), o gastrointestinal dysfunction - Duration of invasive mechanical ventilation, Duration of non-invasive mechanical ventilation - SOFA score at day 1 and day 3 after surgery - Percentage of patients with new organ dysfunction (not present at randomization) - Blood levels of CRP - Proportion of patients who experienced adverse events, especially hyperglycaemia, healing impairment within 7 days after surgery ;Timepoint(s) of evaluation of this end point: 28 days

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Countries

France

Contacts

Public ContactSandrine Cussonneau

CHU de Nantes

sandrine.cussonneau@chu-nantes.fr0033253482430

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026