NCT01354197

Brief Summary

The study observed the 28 days mortality of 9 participated University base surgical intensive care unit (SICU) as well as the occurrence of adverse events in SICU.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,652

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

9 active sites

Status
completed

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

April 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

March 27, 2017

Completed
Last Updated

March 27, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

May 13, 2011

Results QC Date

October 4, 2016

Last Update Submit

February 5, 2017

Conditions

Keywords

Adverse eventsMortalityReadmissionSurgical intensive care unit

Outcome Measures

Primary Outcomes (1)

  • Overall Mortality

    Number of Participants who Did Not Survive up to 28 days after surgical ICU admission

    28 days

Secondary Outcomes (1)

  • Readmission to ICU

    3 days

Study Arms (1)

All ICU admission patients

All ICU admission to surgical intensive care unit at cohort time

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All SICU admission patients

You may qualify if:

  • All SICU admission patients

You may not qualify if:

  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Department of Surgery and Department of Anesthesiology, Bangkok metropolitan medical college and Vajira hospital

Bangkok, Bangkok, 10300, Thailand

Location

Department of Anesthesiology, Faculty of Medicine, Chulalongkorn hospital

Bangkok, Bangkok, 10400, Thailand

Location

Department of Anesthesiology, Faculty of Medicine, Ramathibodi hospital

Bangkok, Bangkok, 10400, Thailand

Location

Department of Surgery, Pramongkudklao hospital

Bangkok, Bangkok, 10400, Thailand

Location

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

Department of Surgery, Faculty of Medicine, Maharaj Nakorn Chiang Mai hospital

Chiang Mai, Chiang Mai, 50200, Thailand

Location

Department of Anesthesiology, Faculty of Medicine, Srinakarin hospital

Khon Kaen, Khon Khon, 40002, Thailand

Location

Department of Anesthesiology

Nakhon Nayok, Nakorn Nayok, 26120, Thailand

Location

Department of Surgery and Department of Anesthesiology

Songkhla, Songkha, 90110, Thailand

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsCritical Illness

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Kaweesak Chittawatanarat
Organization
Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand

Study Officials

  • Suneerat Kongsayreepong, MD.FRCAT

    Mahidol University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 16, 2011

Study Start

April 1, 2011

Primary Completion

November 1, 2012

Study Completion

January 1, 2013

Last Updated

March 27, 2017

Results First Posted

March 27, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

All the data was managed by the the Medical Research Network of the Consortium of Thai Medical Schools (MedResNet)

Locations