The effect of intraoperative fluid status optimisation guided by oesophageal doppler monitoring on outcome of patients following urgent or emergency laparotomy
| ISRCTN | ISRCTN11799696 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11799696 |
| Protocol serial number | G0100043 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 18/05/2001
- Registration date
- 18/05/2001
- Last edited
- 16/11/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John Kinsella
Scientific
Scientific
Department of Anaesthesia
Glasgow Royal Infirmary
University of Glasgow
8-16 Alexandra Parade
Glasgow
G4 0SF
United Kingdom
| Phone | +44 (0)141 211 4625 |
|---|---|
| j.kinsella@clinmed.gla.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | FLOES |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Fluid status in emergency laparotomy |
| Intervention | In the intervention group pulse pressure variation measurements were used to guide fluid boluses of 6% Hydroxyethylstarch 130/0.4 |
| Intervention type | Other |
| Primary outcome measure(s) |
Serum urea, creatinine and cystatin C levels were measured prior to and at the end of surgery and postoperatively on day 1, day 3 and day 5. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 01/05/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key inclusion criteria | Not provided at time of registration. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/05/1999 |
| Date of final enrolment | 01/05/2002 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Department of Anaesthesia
Glasgow
G4 0SF
United Kingdom
G4 0SF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/06/2008 | Yes | No |