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
Scientific
199 Tun Hwa N. Road
Department of Thoracic Medicine
Chang Gung Memorial Hospital
Taipei
105
Taiwan
| Phone | +886 3 3272474 |
|---|---|
| smlin100@hotmail.com |
Study information
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| 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 | |
"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 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 |
