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Postoperative CarePOSTICU-24NCT07856537

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

An observational study of Postoperative Care, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Care
How many people
480 participants
Where
1 siteTurkey (Türkiye)
Study dates
9 Sep 2026to 10 Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

    Istanbul, 34303

    Engin İhsan Turan, MD, +905382431114, enginihsan@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Temporal Distribution and Severity of Complications Within the First 24 Hours in Patients Admitted to the Postoperative Intensive Care Unit

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

Read the detailed description

Design and setting This is a single-centre, prospective, observational cohort study conducted in the postoperative (surgical) intensive care unit of the Department of Anesthesiology and Reanimation of a tertiary training and research hospital. Population Consecutive adult patients (>=18 years) admitted to the ICU for postoperative monitoring after elective or emergency surgery will be enrolled. No study-specific intervention is performed; all patients receive standard clinical care. All data are extracted from routinely collected clinical records: patient charts, anaesthesia records, ICU observation forms, hourly nursing charts, monitor recordings and laboratory results. Time definition The moment of ICU admission is defined as hour 0. All patients are followed from this reference point. Systematic assessments are performed at 0-2, 2-6, 6-8, 8-12 and 12-24 hours. In addition, hourly nursing and monitor records are used to determine the timing of each complication as precisely as possible (hour and, where available, minute level). For every complication, the time of first onset is recorded separately. Data collected Demographic and preoperative data (age, sex, height, weight, body mass index, ASA physical status, comorbidities, preoperative laboratory values, chronic medication); intraoperative data (surgical specialty and procedure type, elective vs emergency status, duration of surgery, anaesthetic technique, intraoperative hypotension or arrhythmia, fluid and blood product administration, vasopressor/inotrope requirement, extubation status); and postoperative ICU monitoring parameters recorded within each time window (heart rate, mean arterial pressure, vasopressor/inotrope use and dose changes, SpO2, respiratory rate, mode of oxygen therapy, mechanical ventilation status, reintubation, hourly urine output, serum creatinine, level of consciousness, sedation/agitation level, delirium assessment where applicable, arterial blood gas, haemoglobin/haematocrit, troponin and lactate where available). Complication assessment Complications are assessed against predefined objective criteria. Only events that are clinically significant and/or require intervention are recorded as complications. For each complication, the time of first onset, the diagnostic criterion applied, the requirement for clinical intervention and whether the event was recurrent are recorded separately.

Where a patient develops more than one complication, each is recorded as a separate event and the time of the first complication is additionally analysed. Predefined complication categories are: acute kidney injury, cardiac arrhythmia, respiratory complications, haemodynamic instability, neurological complications, bleeding and transfusion requirement, and infectious complications. Complication severity is graded using the Clavien-Dindo classification. Complication types, timing of onset and early-window complication rates are analysed separately for each group. 7. Study Design Study Type Observational Observational Study Model Cohort be calculated for the 0-6, 0-8, 8-12 and 12-24 hour windows. Early complication development (first 6-8 hours) will be defined as a binary variable and its capacity to represent the total complication burden will be analysed. Independent risk factors will be identified by logistic regression, with Cox regression where time-dependent effects require assessment. Results will be reported with odds ratios and 95% confidence intervals. Ethics The study will be conducted in accordance with the Declaration of Helsinki and the principles of Good Clinical Practice. All data will be anonymised. The study involves no additional intervention and poses no risk to participants.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07856537
Study groupRoleWhat they receive
Postoperative ICU cohortAdult 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: First 24 hours after ICU admission

Secondary outcomes (5)
  1. Time to first complication

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

    Measured: 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.

    Measured: 6 to 24 hours

  3. Complication severity

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

    Measured: 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

    Measured: 24 hours

  5. Independent risk factors for complication development

    Patient and perioperative variables independently associated with complication development

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2026
  2. Study start9 Sep 2026 (estimated)
  3. Primary completion9 Sep 2027 (estimated)
  4. Study completion10 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07856537
Sponsor's protocol ID
complications
Acronym
POSTICU-24
Status last verified
Sep 2026
First submitted
28 Sep 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Care, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of clinically significant postoperative complications by time (time frame: First 24 hours after ICU admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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