The effect of an intraoperative, goal-directed volume protocol in abdominal surgery within an accelerated recovery program after surgery (Enhanced Recovery Program After Surgery: ERAS-Program)
| ISRCTN | ISRCTN94786070 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94786070 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/02/2008
- Registration date
- 27/03/2008
- Last edited
- 11/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Claudia Spies
Scientific
Scientific
Charitéplatz 1
Berlin
10117
Germany
| claudia.spies@charite.de |
Study information
| Study design | Prospective, randomised, double-blinded, two-arm multi-center trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | ERAS Doppler |
| Study objectives | Primary Hypothesis: In contrast to a liberal volume management strategy there is a difference in the amount of intravenously administered crystalloid and colloid fluid on the day of operation compared to a goal-directed volume protocol within an accelerated surgical recovery program (ERAS-Program). Secondary Hypothesis: The goal-directed perioperative fluid therapy reduces the intraoperative requirement for vasoactive drugs, the time to hospital discharge and the rate of postoperative complications (pain, delirium. infections, cardiac, pulmonary, gastrointestinal and renal dysfunction). As of 03/11/2010 this record has been updated to include an extended anticipated end date; the initial anticipated end date of this trial was 01/02/2010. |
| Ethics approval(s) | Ethics Committee of Charité - University Medicine Berlin, approved on 4th December 2007 |
| Health condition(s) or problem(s) studied | Colonic resection above the peritoneal reflection |
| Intervention | Targeted-volume application guided by esophageal doppler vs conventional volume application |
| Intervention type | Other |
| Primary outcome measure | Difference in the amount of intravenously administered crystalloid and colloid fluid on the day of operation |
| Secondary outcome measures | 1. Reduction of the intraoperative requirement for vasoactive drugs 2. Time to hospital discharge 3. Rate of postoperative complications (pain, delirium. infections, cardiac, pulmonary, gastrointestinal and renal dysfunction). Patients will be monitored until they fulfill the hospital discharge criteria or up to 30th postoperative day. |
| Overall study start date | 05/02/2008 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 42 |
| Key inclusion criteria | 1. Written patient consent 2. Patients who undergo colonic resection above the peritoneal reflection 3. Patients who are treated within the context of an accelerated post-operative recovery program |
| Key exclusion criteria | 1. Accommodation in an institution due to an official or judicial order 2. No written consent from patient 3. Unwillingness to allow storage and sharing of anonymised disease data in the context of the clinical study 4. Simultaneous participation of the patient in another study or having been in a study which was terminated less than one week ago 5. American Society of Anaesthesiologists (ASA) classification >III 6. Advanced disease of the oesophagus of nasopharyngeal cavity 7. Operations in the area of the oesophagus or nasopharynx within the last 3 months 8. Systemic steroid therapy 9. Moderate or severe heart valve disease 10. von Willebrands disease 11. History of bleeding tendency 12. Liver disease (Child B or C cirrhosis, End-Stage Liver Disease [MELD] score >17) 13. Age <18 years 14. Renal failure (serum creatinine >2.0 mg/dL) 15. Chronic heart failure New York Heart Association (NYHA) class III or IV 16. History of intracranial haemorrhage 17. Allergy to hydroxy-ethyl starch |
| Date of first enrolment | 05/02/2008 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Germany
- Netherlands
- Norway
Study participating centre
Charitéplatz 1
Berlin
10117
Germany
10117
Germany
Sponsor information
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
University/education
University/education
Charitéplatz 1
Berlin
10117
Germany
| anaesthesie-virchow-klinikum@charite.de | |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
University/education
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
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 |
