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

Complication Clinical Trial

Official title:

Data Registry of ICU Siamitra and ICU Salad-Samung

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01361477
• Other study ID #: Si227/2011
• Status: Recruiting
• Start date: May 2011
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Mahidol University
• Contact: Suneerat Kongsayreepong, MD
• Phone: +661-8427419
• Email: suneerat.kon[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Surgical patients

Exclusion Criteria:

• Patient undergoing cardiothoracic surgery, traumatic surgery, neurosurgery

Related Conditions & MeSH terms

• Complication

Locations

Country	Name	City	State
Thailand	ICU Siamitra and ICU Salad-Samung, Siriraj Hospital	Bangkoknoi	Bangkok
Thailand	ICU Siamitra and ICU Salad-Samung, Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged ICU stay	Incidence and factors associated with prolonged ICU stay	9 years
Secondary	ICU complication, resource utilization and adverse events/ICU readmission within 72 hours after discharging from ICU	ICU complication, resource utilization and adverse events/ICU admission within 72 hours after discharging from ICU	9 years
Secondary	Unplanned ICU admission	All unplanned ICU Admission (from OR and from floor)	9 years
Secondary	outcome of complications occurring intraoperative and admitting to ICU	all complication including: intraoperative cardiac arrest, hypotension	9 years
Secondary	sepsis and septic shock on ICU admission	incidence, clinical course and outcome of surgical septic shock admitting to ICU	9 years