A Simplified Goal-directed Protocol Improves Clinical Outcomes in Patients with Septic Shock: A Randomized Controlled Trial
ISRCTN | ISRCTN87720456 |
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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
Scientific
199 Tun Hwa N. Road
Department of Thoracic Medicine
Chang Gung Memorial Hospital
Taipei
105
Taiwan
Phone | +886 3 3272474 |
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smlin100@hotmail.com |
Study information
Study design | A Randomized Controlled Trial |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
199 Tun Hwa N. Road
Taipei
105
Taiwan
105
Taiwan
Sponsor information
Chang Gung Memorial Hospital (Taiwan)
Hospital/treatment centre
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 |
---|---|
q8828@ms11.hinet.net | |
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 | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | Results | 01/12/2006 | Yes | No |