Randomised controlled, double blinded single centre trial to assess the effects of peri-operative dopexamine on morbidity after major abdominal surgery in patients with low anaerobic threshold
| ISRCTN | ISRCTN33549216 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33549216 |
| Secondary identifying numbers | DOP06 |
- Submission date
- 01/08/2006
- Registration date
- 18/08/2006
- Last edited
- 19/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Simon Davies
Scientific
Scientific
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
| Phone | +44 (0) 190 463 1313 |
|---|---|
| simon.davies@york.nhs.uk |
Study information
| Study design | Randomised, controlled, double blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | That using a combination of fluid and dopexamine will reduce the post operative morbidity of patients undergoing elective major abdominal surgery who have a low anaerobic threshold. |
| Ethics approval(s) | Approved by York Research Ethics Committee. |
| Health condition(s) or problem(s) studied | Major Abdominal Surgery |
| Intervention | As of 12/03/2008 the anticipated end date of this trial was extended to 1st February 2009. The previous anticipated end date was 1st February 2008. Infusion of dopexamine at 0.5 mcg/kg/min for 24 hours. The control group receives placebo (normal saline) as an infusion for 24 hours. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dopexamine |
| Primary outcome measure | Morbidity at five, ten, and 15 days using the Post-Operative Morbidity Score (POMS) score. |
| Secondary outcome measures | 1. Length of stay in hospital after surgery 2. Recovery parameters (drinking, eating, mobilising) 3. Incidence of post-operative complications 4. Peri-operative haemodynamic variables (heart rate, blood pressure, Central Venous Pressure [CVP]) 5. Physiologic and Operative Severity Score for the enUmeration of Mortality and morbidity (POSSUM) score for surgical risk assessment 6. Oxygen delivery |
| Overall study start date | 01/09/2006 |
| Completion date | 01/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 124 |
| Key inclusion criteria | Patients undergoing scheduled resection for carcinoma of the colon, rectum, bladder, pancreas, stomach or kidney, who, after routine Cardiopulmonary exercise (CPX) testing at the Pre-assessment Clinic, have been found to have an Anaerobic Threshold (AT) less than or equal to 11.0 ml/min/m2 as measured by the V-slope method 15, or with an AT of 11.0 -14.0 ml/min/m2 and ischaemic changes on Electrocardiogram (ECG) monitoring during testing or with a significant history of ischaemic heart disease (New York Heart Association [NYHA] classification III and IV). |
| Key exclusion criteria | 1. Less than 60 years of age unless they have significant co-morbidities (American Society of Anaesthesiologists (ASA) score three or greater) 2. Having emergency or vascular procedures 3. ASA grade five 4. Refuse or are unable to give informed consent 5. Hypertrophic Obstructive Cardiomyopathy, aortic stenosis, phaeochromocytoma, a low platelet count, or have used a monoamine oxidase inhibitor within the last 14 days |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/02/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
York Hospital
York
YO31 8HE
United Kingdom
YO31 8HE
United Kingdom
Sponsor information
York Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
York Hospital
Wigginton Road
York
YO31 8HE
England
United Kingdom
| Phone | +44 (0) 190 463 1313 |
|---|---|
| caroline.mozley@york.nhs.uk | |
| Website | http://www.yorkhealthservices.org/ |
"ROR" |
https://ror.org/027e4g787 |
Funders
Funder type
Research organisation
Association of Anaesthetists (UK)
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 | 01/01/2011 | Yes | No |
