A Simplified Goal-directed Protocol Improves Clinical Outcomes in Patients with Septic Shock: A Randomized Controlled Trial

ISRCTN	ISRCTN87720456
DOI	https://doi.org/10.1186/ISRCTN87720456
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Shu-Min Lin
Scientific

199 Tun Hwa N. Road
Department of Thoracic Medicine
Chang Gung Memorial Hospital
Taipei
105
Taiwan

Phone	+886 3 3272474
Email	smlin100@hotmail.com

Study design	A Randomized Controlled Trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	The institutional review board approved this study
Health condition(s) or problem(s) studied	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
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 study start date	01/07/2003
Completion date	28/02/2004

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	224
Key inclusion criteria	Patients admitted to intensive care unit (ICU) with diagnosis of septic shock were included in this study.
Key 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.
Date of first enrolment	01/07/2003
Date of final enrolment	28/02/2004

199 Tun Hwa N. Road

Taipei
105
Taiwan

Chang Gung Memorial Hospital (Taiwan)
Hospital/treatment centre

Han-Pin Kuo
199 Tun Hwa N. Road
Department of Thoracic Medicine
Chang Gung Memorial Hospital
Taipei
105
Taiwan

Government

NSC-92-2314-B-182A-069, National Science Council, Taiwan, R.O.C

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/12/2006		Yes	No