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
Submission date
24/11/2005
Registration date
28/11/2005
Last edited
15/05/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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 information

Study designA Randomized Controlled Trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesWe 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) studiedSeptic shock
InterventionThe 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 typeOther
Primary outcome measureICU and in-hospital mortality
Secondary outcome measuresLength of ICU stay, length of hospital stay, and duration of mechanical ventilation.
Overall study start date01/07/2003
Completion date28/02/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants224
Key inclusion criteriaPatients admitted to intensive care unit (ICU) with diagnosis of septic shock were included in this study.
Key exclusion criteriaExclusion 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 enrolment01/07/2003
Date of final enrolment28/02/2004

Locations

Countries of recruitment

  • Taiwan

Study participating centre

199 Tun Hwa N. Road
Taipei
105
Taiwan

Sponsor information

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

Phone +886 3 3272474
Email q8828@ms11.hinet.net
ROR logo "ROR" https://ror.org/02verss31

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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