Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial

Abstract

BackgroundEmergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients.Methods and designThe InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power.DiscussionThis trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care.Trial registrationClinicaltrials.gov identifier: NCT01209663

Randomized multicentre feasibility trial of intermediate care versus standard ward care after emergency abdominal surgery (InCare trial)

“…Emergency surgery was defined as surgery to be undertaken within 24 h. The APACHE II index was used to select high‐risk surgical patients. A score of 10 or above reflects the presence of perioperative sepsis, cardiovascular and/or respiratory failure (index range in emergency surgical patients 5–71). To increase the enrolment rate, the APACHE II score threshold was lowered from the original limit of at least 12 to 10 or more on 23 May 2012 after enrolment of 192 patients.…”

“…An intermediate care unit monitors and supports patients with, or likely to develop, acute single‐organ failure. However, according to the authors' knowledge, the effect of postoperative intermediate care compared with standard ward care has never been evaluated in a randomized clinical trial.…”

Patients' experiences of postoperative intermediate care and standard surgical ward care after emergency abdominal surgery: a qualitative sub‐study of the Incare trial

“…Participants were randomised to 48‐hour postoperative intermediate care in an intensive care unit or standard postoperative care in a surgical ward (Vester‐Andersen et al . ). Postoperative intermediate care included continuous monitoring of heart rate, blood pressure, pulse oximetry, level of consciousness, nutrition and postoperative pain.…”

“…Therefore, a pilot trial of an enhanced postoperative care intervention, the InCare trial, was undertaken (Vester‐Andersen et al . ).…”

The Role of Stepdown Beds in Hospital Care

“…Other studies have failed to find a mortality benefit attributable to the establishment of an SDU or SDU-level care itself (9,38,42,45). The ongoing InCare trial in Denmark is explicitly focused on mortality associated with postoperative SDU care versus ward care after major abdominal emergency surgery (54), and will be the first major multicenter trial evaluating outcomes attributable to different levels of postoperative care.…”