Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Timing of Complications in the First 24 Hours After Admission to a Postoperative (POSTICU-24)

28 settembre 2026 aggiornato da: Engin Ihsan Turan, Kanuni Sultan Suleyman Training and Research Hospital

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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

480

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Istanbul, Turchia (Türkiye), 34303
        • Reclutamento
        • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cumulative incidence of clinically significant postoperative complications by time
Lasso di tempo: First 24 hours after ICU admission

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to first complication
Lasso di tempo: 24 hour

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

24 hour
New complications after an event-free first 6 hours
Lasso di tempo: 6 to 24 hours

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

6 to 24 hours
Complication severity
Lasso di tempo: 24 hours

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

24 hours
Complication type and timing by surgical specialty
Lasso di tempo: 24 hours

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

24 hours
Independent risk factors for complication development
Lasso di tempo: 24 hours

Patient and perioperative variables independently associated with complication development

24 hours

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

9 settembre 2026

Completamento primario (Stimato)

9 settembre 2027

Completamento dello studio (Stimato)

10 settembre 2027

Date di iscrizione allo studio

Primo inviato

28 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 settembre 2026

Primo Inserito (Effettivo)

2 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • complications

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi