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van CCT (UK)

van CCT (UK)

Dexamethasone for Cardiac Surgery study

- candidate number2829
- NTR NumberNTR1102
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2007
- Secondary IDsDECS UMC Utrecht, DP&S
- Public TitleDexamethasone for Cardiac Surgery study
- Scientific TitleDexamethasone for Cardiac Surgery study: a large, simple trial of dexamethasone versus placebo in patients undergoing cardiac surgery.
- hypothesisA single, prophylactic dose of dexamethasone during cardiac surgery reduces the incidence of major postoperative complications.
- Healt Condition(s) or Problem(s) studiedSystemic inflammatory response syndrome (SIRS)
- Inclusion criteriaAll types of cardiac surgery in which cardiopulmonary bypass is used.
- Exclusion criteria1. Age under 18 years;
2. Life-expectancy <6 months;
3. Emergency operations;
4. Re-operations within the same admission.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2006
- planned closingdate1-sep-2010
- Target number of participants4500
- InterventionsAdministration of dexamethasone 1 mg/kg, or placebo.
- Primary outcomeThe primary endpoint is the occurrence of major complications (including all-cause mortality, myocardial infarction, stroke, renal failure, and prolonged mechanical ventilation) in the first 30 days after surgery.
- Secondary outcome1. The occurrence of one or more major complications within the first year after surgery;
2. the separate components of the primary outcome measure, i.e. major complications in the first 30 days after surgery;
3. quality of life at 30 days and one year after surgery;
4. wound infection in the first 30 days after surgery;
5. use of anti-anginal drugs at 30 days after surgery;
6. atrial fibrillation in ICU;
7. highest serum glucose concentration in ICU;
8. use of inotropes on the first postoperative day;
9. highest body temperature in ICU;
10. time to extubation;
11. time to discharge from ICU;
12. time to discharge from hospital;
13. change in cognitive performance from before to 30 days after surgery (subsample of 400 patients);
14. serum glucose-values and insulin use in ICU (subsample of patients in the UMC Utrecht);
15. cost-effectiveness analysis.
- Timepoints1. 30 days (prim);
2. 1 year (sec).
- Trial web
- statusopen: patient inclusion
- Sponsor/Initiator UMC Utrecht, Division of Perioperative Care & Emergency
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Dutch Heart Foundation (Nederlandse Hartstichting)
- PublicationsN/A
- Brief summaryRationale
Cardiac surgery is associated with a postoperative systemic inflammatory response syndrome, which may contribute to mortality, myocardial infarction and other major complications. The inflammatory response can be suppressed with high dose corticosteroids, typically an intraoperative intravenous injection of dexamethasone 1 mg/kg. The use of high dose corticosteroids, however, can have a multitude of unwanted side effects including immunosuppression, poor wound healing, inadequate glucose control, fluid retention, hypertension, electrolyte imbalances, higher lactate levels, and gastrointestinal blood loss. These side effects themselves could contribute to the rate of major complications. At present, there is no evidence from clinical trials whether steroids increase or decrease the risk of major perioperative complications. As a result, the use of steroids in heart surgery is highly controversial and varies greatly across the countries where heart surgery is performed.

Study Objective
To determine whether the proportion of patients with one or more major complications (mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation) in the first month after cardiac surgery, is reduced by intra-operative administration of dexamethasone. Secondary objectives include an evaluation of the impact of dexamethasone on major complications at 1 year follow-up.

Study Design
This is a large but simple multi-centre, double-blinded, randomized controlled trial of dexamethasone versus placebo in 4,500 adult patients undergoing cardiac surgery.

Patients are eligible if they are undergoing cardiac and are 18 years or older.

Study Drug Administration
Patients will be randomized to receive a single intravenous injection of dexamethasone 1 mg/kg, or a single intravenous injection of placebo, immediately after induction of anesthesia. Trial medication (dexamethasone or placebo) is administered by the attending anesthetist. Patients and treating physicians are blinded for treatment allocation.

A limited set of data will be collected during the patientís hospital stay. The occurrence of one or more major complications will be determined at the 30th day after surgery. There will also be a long term follow-up at 1 year.
- Main changes (audit trail)
- RECORD21-okt-2007 - 25-mrt-2008

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