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
Protocol serial number	N/A
Sponsor	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Funder	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

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

Charitéplatz 1
Berlin
10117
Germany

Email	claudia.spies@charite.de

Study information

Primary study design	Interventional
Study design	Prospective, randomised, double-blinded, two-arm multi-center trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Difference in the amount of intravenously administered crystalloid and colloid fluid on the day of operation
Key secondary outcome measure(s)	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.
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes