NCT01361477

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
13.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

13.3 years

First QC Date

May 25, 2011

Last Update Submit

October 30, 2023

Conditions

Keywords

General surgical ICUICU SiamitraICU Salad-SamungData registryICU refusalICU complicationsICU resource utilizationAdverse eventsICU readmissionintraoperative hypotensionintraoperative cardiac arrest

Outcome Measures

Primary Outcomes (1)

  • Prolonged ICU stay

    Incidence and factors associated with prolonged ICU stay

    9 years

Secondary Outcomes (4)

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

    9 years

  • Unplanned ICU admission

    9 years

  • outcome of complications occurring intraoperative and admitting to ICU

    9 years

  • sepsis and septic shock on ICU admission

    9 years

Study Arms (1)

patient

1. Prolonged ICU stay 2. Unplanned ICU admission 3. Complication/adversel during ICU admission 4. Result of intraoperative complications and admission to ICU 5 Result of early postoperative (within 7 days) and ICU admission

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult (\> 18 years), admitting to ICU Siamitra and ICU Salad-Samung

You may qualify if:

  • Age \> 18 years
  • Surgical patients

You may not qualify if:

  • Patient undergoing cardiothoracic surgery, traumatic surgery, neurosurgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ICU Siamitra and ICU Salad-Samung, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

ICU Siamitra and ICU Salad-Samung, Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (1)

  • Capuzzo M, Moreno RP, Alvisi R. Admission and discharge of critically ill patients. Curr Opin Crit Care. 2010 Oct;16(5):499-504. doi: 10.1097/MCC.0b013e32833cb874.

Study Officials

  • Suneerat Kongsereepong, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suneerat Kongsayreepong, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 25, 2011

First Posted

May 26, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations