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Data Registry of Intensive Care Unit (ICU) Siamitra and Intensive Care Unit (ICU) Salad-Samung

Sponsor
Mahidol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT01361477
Collaborator
(none)
2,000
Enrollment
2
Locations
133
Anticipated Duration (Months)
1000
Patients Per Site
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

As a general surgical intensive care units of the biggest tertiary referral university of Thailand with more than 1,000 admissions/year, recently, more complicated perioperative care surgical patients were accepted with high complications, morbidities, mortality and resource utilization. Good data registration was needed to provide information for quality improvement and resource allocation. This prospective observational (crosssectional) study was designed to register patient > 18 years who will be admitted to these ICUs to explore the adequacy of these ICUs services, resource utilization (ICU length of stay and ventilator day), ICU complications, adverse outcome /ICU readmission within 72 hours after discharging from ICU. In addition, severe hemodynamic, respiratory, or neurological disturbance or complication intra and early postoperative (within 7 days after operation) that lead to ICU admission eg, intraoperative hypotension, intraoperative cardiac arrest, perioperative pulmonary aspirtaion will also be studied.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This prospective obseverational study wae ans will be done in all surgical patient (age . 18 yeras) admitted to the general surgical ICU (ICU Siammitra and ICU Salad-sumang) of the Department of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol UNiversity, Bangkok, Thailand. After approval by the IRB of Siriaj Hospital, all information of the patients admiited to the ICUs were carefully recorded included patient demographic data, comorbidities, type of anesthesia, type of surgery, complication associated with anesthesia and surgery, type of ICU admission and course in ICU including outcome as Iresouce utilization (cost in ICU, ventilator day, ICU and hosital length of stay. Morbidity occcuring in ICU, 28 and 90 days mortality also recorded.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Data Registry of ICU Siamitra and ICU Salad-Samung
    Actual Study Start Date :
    May 1, 2011
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    patient

    Prolonged ICU stay Unplanned ICU admission Complication/adversel during ICU admission Result of intraoperative complications and admission to ICU 5 Result of early postoperative (within 7 days) and ICU admission

    Outcome Measures

    Primary Outcome Measures

    1. Prolonged ICU stay [9 years]

      Incidence and factors associated with prolonged ICU stay

    Secondary Outcome Measures

    1. ICU complication, resource utilization and adverse events/ICU readmission within 72 hours after discharging from ICU [9 years]

      ICU complication, resource utilization and adverse events/ICU admission within 72 hours after discharging from ICU

    2. Unplanned ICU admission [9 years]

      All unplanned ICU Admission (from OR and from floor)

    3. outcome of complications occurring intraoperative and admitting to ICU [9 years]

      all complication including: intraoperative cardiac arrest, hypotension

    4. sepsis and septic shock on ICU admission [9 years]

      incidence, clinical course and outcome of surgical septic shock admitting to ICU

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age > 18 years

    • Surgical patients

    Exclusion Criteria:
    • Patient undergoing cardiothoracic surgery, traumatic surgery, neurosurgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ICU Siamitra and ICU Salad-Samung, Siriraj Hospital, Mahidol University Bangkoknoi Bangkok Thailand 10700
    2 ICU Siamitra and ICU Salad-Samung, Siriraj Hospital Bangkoknoi Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Suneerat Kongsereepong, MD, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suneerat Kongsayreepong, MD, Professor, Mahidol University
    ClinicalTrials.gov Identifier:
    NCT01361477
    Other Study ID Numbers:
    • Si227/2011
    First Posted:
    May 26, 2011
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Suneerat Kongsayreepong, MD, Professor, Mahidol University
    General surgical ICU
    ICU Siamitra
    ICU Salad-Samung
    Data registry
    ICU refusal
    ICU complications
    ICU resource utilization
    Adverse events
    ICU readmission
    intraoperative hypotension
    intraoperative cardiac arrest

    Study Results

    No Results Posted as of Apr 21, 2022