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

This study has been terminated.
(30th November 2012. Please see breif summary.)
Sponsor:
Collaborators:
University of Copenhagen
Copenhagen Trial Unit, Centre for Clinical Intervention Research
The Research Council Herlev University Hospital
Sygekassernes Helsefond
Danish Council for Independent Research
AP Moeller Foundation
Lundbeck Foundation
Hilleroed Hospital
Koege Sygehus
Bispebjerg Hospital
Herning Hospital
Aabenraa Hospital
Vejle Hospital
Information provided by (Responsible Party):
Morten Vester-Andersen, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01209663
First received: September 24, 2010
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Emergency Abdominal Surgery
Other: Postoperative Intermediate Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • All cause mortality rate [ Time Frame: Within 30 days of surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • long term mortality [ Time Frame: Until 30 days after the last patient is enrolled in the trial ] [ Designated as safety issue: No ]
  • rate of critical care unit admission from ward [ Time Frame: Within 30 days of surgery ] [ Designated as safety issue: No ]
  • Postoperative hospitalization time [ Time Frame: until 30 days after the last patient is enrolled in the trial ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209663

Locations
Denmark
Copenhagen University, Bispebjerg Hospital
Copenhagen, DK, Denmark, 2400
Herning Regional Hospital
Herning, DK, Denmark, 7400
Aabenraa Hospital
Aabenraa, Denmark, DK-6200
Herlev University Hospital
Copenhagen, Denmark, DK-2730
Copehagen University, Hilleroed Hospital
Hilleroed, Denmark, DK-3400
Copenhagen University, Koege Hospital
Koege, Denmark, DK-4600
Sygehus Lillebaelt, Vejle Hospital
Vejle, Denmark, DK-7100
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
University of Copenhagen
Copenhagen Trial Unit, Centre for Clinical Intervention Research
The Research Council Herlev University Hospital
Sygekassernes Helsefond
Danish Council for Independent Research
AP Moeller Foundation
Lundbeck Foundation
Hilleroed Hospital
Koege Sygehus
Bispebjerg Hospital
Herning Hospital
Aabenraa Hospital
Vejle 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
  More Information

Additional Information:
No publications provided by Copenhagen University Hospital at Herlev

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Morten Vester-Andersen, MD, Senior resident, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01209663     History of Changes
Other Study ID Numbers: H-3-2010-010
Study First Received: September 24, 2010
Last Updated: December 5, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Copenhagen University Hospital at Herlev:
General Surgery
Emergency treatment
Postoperative care
Intermediate care unit
High dependency unit
Mortality

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014