Condition category
Infections and Infestations
Date applied
24/11/2005
Date assigned
28/11/2005
Last edited
15/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17117128

Publication citations

  1. 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.

Additional files

Editorial Notes