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

NCT07856537 | Recruiting DMC

• 1 other identifier: complications
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Care

Outcome Measures

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.

  First 24 hours after ICU admission

Secondary Outcomes (5)

• Time to first complication

  24 hour

• New complications after an event-free first 6 hours

  6 to 24 hours

• Complication severity

  24 hours

• Complication type and timing by surgical specialty

  24 hours

• Independent risk factors for complication development

  24 hours

Study Arms (1)

Postoperative ICU cohort

Adult patients admitted to the postoperative (surgical) intensive care unit for routine postoperative monitoring following elective or emergency surgery. No study intervention is applied; patients are observed under standard clinical care for the first 24 hours after ICU admission. Prespecified subgroup analyses are performed by surgical specialty.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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
• Time of ICU admission and course of monitoring reliably documented

You may not qualify if:

• 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
• Time of complication onset cannot be reliably determined, or records are inadequate
• Incomplete data for the first 24 hours of ICU monitoring
• Terminal illness managed with a palliative approach

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: September 9, 2026
• Primary Completion (Estimated): September 9, 2027
• Study Completion (Estimated): September 10, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

TU (1)