Timing of Complications in the First 24 Hours After Admission to a Postoperative

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKanuni Sultan Suleyman Training and Research Hospital

About this trial

The optimal duration and intensity of intensive care monitoring after surgery is largely determined by clinical experience rather than by objective, time-based evidence. This prospective observational cohort study aims to determine how frequently clinically significant complications occur in adult patients admitted to a postoperative intensive care unit (ICU), and - more specifically - when they occur during the first 24 hours after ICU admission. Patients will be followed under standard clinical care, with no additional intervention.

The time of ICU admission is defined as hour 0. Complications are recorded with their exact time of first onset, and cumulative incidence is calculated for the predefined windows 0-2, 2-6, 6-8, 8-12 and 12-24 hours. The study will assess whether complications cluster in the early postoperative period (first 6-8 hours) and what proportion of the total 24-hour complication burden this early window represents. A separate analysis will determine how often patients who remain complication-free during the first 6 hours subsequently develop a new, clinically significant complication. The findings are intended to inform evidence-based decisions about the required duration of close postoperative ICU monitoring

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Underwent elective or emergency surgery

Admitted to the intensive care unit for postoperative monitoring after surgery

Monitored in the ICU for at least 24 hours, or sufficient clinical data available for the first 24 hours of monitoring

Disqualifiers

Age under 18 years

Pre-existing active organ failure before surgery (for example preoperative acute kidney injury, sustained arrhythmia, requirement for invasive mechanical ventilation)

Admitted to the ICU because of continuing critical illness rather than for monitoring of new postoperative complications

Already an ICU inpatient before surgery and readmitted to the ICU postoperatively

Trial population

Adult patients admitted to the postoperative (surgical) intensive care unit of a tertiary training and research hospital for postoperative monitoring following elective or emergency surgery.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

480 Participants
are grouped into 1 trial group
Group A: Postoperative ICU cohort

Trial outcomes

Primary outcomes

1

Cumulative incidence of clinically significant postoperative complications by time

Number and percentage of patients developing at least one predefined, clinically significant postoperative complication within each time window after ICU admission (0-2, 2-6, 6-8, 8-12 and 12-24 hours). Complication categories are acute kidney injury,arrhythmia, respiratory complications, haemodynamic instability, neurological complications, bleeding requiring transfusion, and infectious complications. Only events meeting predefined objective diagnostic criteria and judged clinically significant and/or requiring intervention are counted.

Time frame
First 24 hours after ICU admission

Secondary outcomes

1

Time to first complication

Time in hours from ICU admission to onset of the first clinically significant complication

Time frame
24 hour
2

New complications after an event-free first 6 hours

Proportion of patients free of any clinically significant complication during the first 6 hours who subsequently develop a new clinically significant complication.

Time frame
6 to 24 hours
3

Complication severity

Severity of each recorded complication graded by the Clavien-Dindo classification

Time frame
24 hours
4

Complication type and timing by surgical specialty

Distribution of complication categories and time of first onset, analysed separately for each surgical specialty subgroup

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.