Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery (InCare)

June 23, 2015 updated by: Morten Vester-Andersen, Copenhagen University Hospital at Herlev

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Like Denmark, many European countries has only limited access to surgical intermediate care beds (high dependency beds). This may reflect lack of scientific evidence for the effect of intermediate care combined with restricted healthcare resources. Better access to dedicated postoperative intensive/intermediate care facilities has been suggested as a factor which potentially can reduce postoperative complication rate and mortality in high risk surgical patients. The Incare Trial will provide important data on the effect of postoperative intermediate care in emergency abdominal surgery patients.

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aabenraa, Denmark, DK-6200
        • Aabenraa Hospital
      • Copenhagen, Denmark, DK-2730
        • Herlev University Hospital
      • Hilleroed, Denmark, DK-3400
        • Copehagen University, Hilleroed Hospital
      • Koege, Denmark, DK-4600
        • Copenhagen University, Koege Hospital
      • Vejle, Denmark, DK-7100
        • Sygehus Lillebaelt, Vejle Hospital
    • DK
      • Copenhagen, DK, Denmark, 2400
        • Copenhagen University, Bispebjerg Hospital
      • Herning, DK, Denmark, 7400
        • Herning Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Emergency laparotomy patients treated by general surgeons OR
  • Emergency laparoscopic surgery patients treated by general surgeons OR
  • Re-operative patients who go through emergency laparotomy or laparoscopy.

AND

  • APACHE II score ≥ 10 AND
  • Patients who are ready to be discharged to the surgical ward after postoperative stay in the recovering unit or an intermediate/intensive care bed

Exclusion Criteria:

  • Appendectomy
  • Emergency laparoscopic cholecystectomy
  • Emergency diagnostic laparoscopy without intervention
  • Postoperative stay in the recovery unit or an intermediate/intensive care bed in more then 24 hours before randomization
  • Patients who should not be offered postoperative intensive care
  • Patients who have been included in the study earlier
  • Age < 18 years
  • Trauma patients

Because of slower enrolment rate than anticipated the steering committee have decided on the 3rd of May 2012 to include patients with Apache II score of 10 and 11 although the originally inclusion criteria was Apache II score 12 or above. Patients with Apache II score of 10 and 11 have a high 30 day mortality as well and the potential to benefit from intermediate care. The new criteria was initiated on the 23rd of May 2012 after ethical approval was obtained.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ward Care
Protocol based discharge to the surgery ward. Observation and treatment is conducted by ward nurses and general surgeons (current treatment).
Other: Postoperative Intermediate Care
Comparison of postoperative Intermediate Care versus Ward Care.
Other Names:
  • High dependency bed
  • High dependency unit
Experimental: Intermediate Care
Observation and treatment in an intermediate care bed in a minimum of 48 hours after randomization. Daily rounds will be carried out by both general surgeons and intensive care physicians.
Other: Postoperative Intermediate Care
Comparison of postoperative Intermediate Care versus Ward Care.
Other Names:
  • High dependency bed
  • High dependency unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality rate
Time Frame: Within 30 days of surgery
Within 30 days of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
long term mortality
Time Frame: Until 30 days after the last patient is enrolled in the trial
Until 30 days after the last patient is enrolled in the trial
rate of critical care unit admission from ward
Time Frame: Within 30 days of surgery
Within 30 days of surgery
Postoperative hospitalization time
Time Frame: until 30 days after the last patient is enrolled in the trial
until 30 days after the last patient is enrolled in the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Collaborators

Zealand University Hospital
University of Copenhagen
Bispebjerg Hospital
Herning Hospital
Herlev Hospital
Lundbeck Foundation
Vejle Hospital
Sygekassernes Helsefond
Danish Council for Independent Research
AP Moeller Foundation
Copenhagen Trial Unit, Center for Clinical Intervention Research
Aabenraa Hospital
Hilleroed Hospital

Investigators

  • Principal Investigator: Morten Vester-Andersen, MD, Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
  • Study Chair: Ann M Møller, MD, PhD, Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
  • Study Chair: Jørn Wetterslev, MD, PhD, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Rigshospitalet
  • Study Chair: Jacob Rosenberg, MD, Prof, Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev
  • Study Chair: Tina Waldau, MD, PhD, Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
  • Study Chair: Morten H Møller, MD, PhD, Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Bispebjerg
  • Study Chair: Flemming Moesgaard, MD, PhD, Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev
  • Study Chair: Lars N Jørgensen, MD, Prof., Department of Gastrointestinal Surgery, Copenhagen University Hospital Bispebjerg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 24, 2010

First Submitted That Met QC Criteria

September 24, 2010

First Posted (Estimate)

September 27, 2010

Study Record Updates

Last Update Posted (Estimate)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 23, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2010-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Emergency Abdominal Surgery

Clinical Trials on Postoperative Intermediate Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe