Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery

Emergency Abdominal Surgery Clinical Trial

— InCare  

Official title:

Intermediate Care - Effect on Mortality Following Emergency Abdominal Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01209663
• Other study ID #: H-3-2010-010
• Status: Terminated
• Phase: N/A
• First received: September 24, 2010
• Last updated: June 23, 2015
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2015
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 286
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Emergency Abdominal Surgery

Intervention

Other:
• Postoperative Intermediate Care
Comparison of postoperative Intermediate Care versus Ward Care.

Locations

Country	Name	City	State
Denmark	Aabenraa Hospital	Aabenraa
Denmark	Copenhagen University, Bispebjerg Hospital	Copenhagen	DK
Denmark	Herlev University Hospital	Copenhagen
Denmark	Herning Regional Hospital	Herning	DK
Denmark	Copehagen University, Hilleroed Hospital	Hilleroed
Denmark	Copenhagen University, Koege Hospital	Koege
Denmark	Sygehus Lillebaelt, Vejle Hospital	Vejle

Sponsors (14)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	Aabenraa Hospital, AP Moeller Foundation, Bispebjerg Hospital, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Danish Council for Independent Research, Herlev Hospital, Herning Hospital, Hilleroed Hospital, Koege Sygehus, Lundbeck Foundation, Sygekassernes Helsefond, University of Copenhagen, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality rate		Within 30 days of surgery	Yes
Secondary	long term mortality		Until 30 days after the last patient is enrolled in the trial	No
Secondary	rate of critical care unit admission from ward		Within 30 days of surgery	No
Secondary	Postoperative hospitalization time		until 30 days after the last patient is enrolled in the trial	No