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

28 de septiembre de 2026 actualizado por: 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

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

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 de estudio

De observación

Inscripción (Estimado)

480

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Istanbul, Turquía (Türkiye), 34303
        • Reclutamiento
        • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: COHORT
  • Perspectivas temporales: PROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cumulative incidence of clinically significant postoperative complications by time
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to first complication
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 24 hours

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

24 hours
Complication type and timing by surgical specialty
Periodo de tiempo: 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
Periodo de tiempo: 24 hours

Patient and perioperative variables independently associated with complication development

24 hours

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

9 de septiembre de 2026

Finalización primaria (Estimado)

9 de septiembre de 2027

Finalización del estudio (Estimado)

10 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

28 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de septiembre de 2026

Publicado por primera vez (Actual)

2 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • complications

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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