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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01361477
First received: May 25, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

As 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 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 for 1 years to explore the adequacy of these ICUs services, resource utilization (ICU length of stay and ventilator day), ICU complications and adverse outcome /ICU readmission within 72 hours after discharging from ICU.


Condition
Complication

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Data Registry of ICU Siamitra and ICU Salad-Samung

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Incidence of ICU refusal [ Time Frame: 1 years ] [ Designated as safety issue: No ]
    The primary outcome measure of this study is the incidence of ICU refusal


Secondary Outcome Measures:
  • ICU complication, resource utilization and adverse events/ICU readmission within 72 hours after discharging from ICU [ Time Frame: 1 years ] [ Designated as safety issue: No ]
    The secondary outcomes of this study are to study ICU complication, resource utilization and adverse events/ICU admission within 72 hours after discharging from ICU


Estimated Enrollment: 1000
Study Start Date: May 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
patient
complication, refusal ICU admission, adverse event

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult (> 18 years), admitting to ICU Siamitra and ICU Salad-Samung

Criteria

Inclusion Criteria:

  • Age > 18 years
  • Surgical patients
  • Written informed consent to this study

Exclusion Criteria:

  • Patient undergoing cardiothoracic surgery, traumatic surgery, neurosurgery
  • Not consent to this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361477

Locations
Thailand
ICU Siamitra and ICU Salad-Samung, Siriraj Hospital Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Suneerat Kongsereepong, MD    011662-4197990    sisko@mahidol.ac.th   
Contact: Onuma Chaiwat, MD    011662-4197990    sioca@mahidol.ac.th   
ICU Siamitra and ICU Salad-Samung, Siriraj Hospital, Mahidol University Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Suneerat Kongsereepong, MD    011662-4197990    sisko@mahidol.ac.th   
Principal Investigator: Suneerat Kongsereepong, MD         
Sub-Investigator: Onuma Chaiwat         
Sub-Investigator: Thitigunya Doungrat, MD         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Suneerat Kongsereepong, MD Mahidol University
  More Information

Publications:
Responsible Party: Prof. Suneerat Kongsereepong, MD, Siriraj Hospital, Mahidol University, Bangkok, Thailnad
ClinicalTrials.gov Identifier: NCT01361477     History of Changes
Other Study ID Numbers: Si227/2011
Study First Received: May 25, 2011
Last Updated: May 25, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
General surgical ICU
ICU Siamitra
ICU Salad-Samung
Data registry
ICU refusal
ICU complications
ICU resource utilization
Adverse events
ICU readmission

ClinicalTrials.gov processed this record on October 23, 2014