Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery

Summary

The objective of this trial is to evaluate postoperative intermediate care versus ward care in patients who have undergone emergency abdominal surgery with a perioperative Acute Physiology and Chronic Health Evaluation (APACHE) II score ≥ 10 (high risk patients).

Patients will be enrolled in the trial, if they are ready to be discharged from the recovery unit or intensive/intermediate care unit to the surgical ward within 24 hours after surgery. Discharge criteria will be according to the Danish national recommendation.

The intermediate care bed in the trial is defined by a certain minimum requirements to patient observation and described treatment possibilities which have to be available to the intermediate bed. If the treatment exceeds these treatment possibilities, the patient will be classified as an intensive care patient. The intermediate care bed will be placed at an intensive care unit, recovery unit or a surgical high dependency unit. If there is no available intermediate care bed, the patients will not be randomized, but only registered as "excluded because of no available intermediate care bed".

Hypothesis: Postoperative intermediate care for 48 hours or more will reduce the 30-day mortality in emergency abdominal surgery patients with a high risk of postoperative organ failure.

Interim analysis: An independent Data Monitoring and Safety Committee (DMSC) will conducted the interim analysis based on the analysis of the primary outcome blinded for intervention allocation. The DMSC will use P\<0.001 (Haybittle-Peto) on two subsequent interim analyses as the statistical limit to guide its recommendations regarding early termination of the trial for benefit or harm. The first interim analysis will be conducted when the 30 days follow-up data of about 50% (i.e., about 200 patients) of the trial participants have been obtained and/or 75 deaths have been documented during the trial. If P\<0,001 in the first interim analysis a second interim analysis will be conducted when the 30 days follow-up data of about 75% (i.e., about 300 patients) of the trial participants have been obtained and/or 25 deaths have been documented during the trial.

Trial terminated on the 30th November 2012. The Data Monitor Committee found a very low overall event rate of the primary outcome at the first interim-analysis as compared to the pre-trial estimated. This precluding any possibility to detect or reject the anticipated relative risk reduction of 34 % as used in the sample size estimation.

Conditions

• Emergency Abdominal Surgery

Interventions

OTHER

Postoperative Intermediate Care

Comparison of postoperative Intermediate Care versus Ward Care.

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Sygekassernes Helsefond

  collaborator OTHER

• Danish Council for Independent Research

  collaborator OTHER

• AP Moeller Foundation

  collaborator OTHER

• Lundbeck Foundation

  collaborator OTHER

• Hilleroed Hospital

  collaborator UNKNOWN

• Zealand University Hospital

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Herning Hospital

  collaborator OTHER

• Aabenraa Hospital

  collaborator OTHER

• Vejle Hospital

  collaborator OTHER

• Copenhagen University Hospital at Herlev

  lead OTHER

Principal Investigators

• Morten Vester-Andersen, MD · Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev

• Ann M Møller, MD, PhD · Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev

• Jørn Wetterslev, MD, PhD · Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Rigshospitalet

• Jacob Rosenberg, MD, Prof · Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev

• Tina Waldau, MD, PhD · Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev

• Morten H Møller, MD, PhD · Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Bispebjerg

• Flemming Moesgaard, MD, PhD · Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev

• Lars N Jørgensen, MD, Prof. · Department of Gastrointestinal Surgery, Copenhagen University Hospital Bispebjerg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2012-11-30

Completion

2012-12-31

Countries

• Denmark

Study Locations