Contact information
Type
Scientific
Primary contact
Dr Shu-Min Lin
ORCID ID
Contact details
199 Tun Hwa N. Road
Department of Thoracic Medicine
Chang Gung Memorial Hospital
Taipei
105
Taiwan
+886 3 3272474
smlin100@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
We sought to evaluate whether a goal-directed protocol, without measurement of central venous oxygen saturation (ScVO2), would improve survival in patients with septic shock.
Ethics approval
The institutional review board approved this study
Study design
A Randomized Controlled Trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Septic shock
Intervention
The patients with septic shock were randomly assigned to receive therapy with or without a written protocol utilizing central venous pressure, mean arterial pressure and urine output as therapeutic goals.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
ICU and in-hospital mortality
Secondary outcome measures
Length of ICU stay, length of hospital stay, and duration of mechanical ventilation.
Overall trial start date
01/07/2003
Overall trial end date
28/02/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients admitted to intensive care unit (ICU) with diagnosis of septic shock were included in this study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
224
Participant exclusion criteria
Exclusion criteria included age less than 18 years, pregnancy, or the presence of an acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, cardiac dysrhythmias (as a primary diagnosis), active gastrointestinal hemorrhage, seizure, drug overdose, burn injury, trauma, a requirement for immediate surgery, uncured cancer, immunosuppression, do-not-resuscitate status, or patient or family refusal to participate.
Recruitment start date
01/07/2003
Recruitment end date
28/02/2004
Locations
Countries of recruitment
Taiwan
Trial participating centre
199 Tun Hwa N. Road
Taipei
105
Taiwan
Sponsor information
Organisation
Chang Gung Memorial Hospital (Taiwan)
Sponsor details
Han-Pin Kuo
199 Tun Hwa N. Road
Department of Thoracic Medicine
Chang Gung Memorial Hospital
Taipei
105
Taiwan
+886 3 3272474
q8828@ms11.hinet.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NSC-92-2314-B-182A-069, National Science Council, Taiwan, R.O.C
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Publication citations
-
Results
Lin SM, Huang CD, Lin HC, Liu CY, Wang CH, Kuo HP, A modified goal-directed protocol improves clinical outcomes in intensive care unit patients with septic shock: a randomized controlled trial., Shock, 2006, 26, 6, 551-557, doi: 10.1097/01.shk.0000232271.09440.8f.