Condition category
Digestive System
Date applied
04/02/2008
Date assigned
27/03/2008
Last edited
11/08/2011
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

Prof Claudia Spies

ORCID ID

Contact details

Charitéplatz 1
Berlin
10117
Germany
claudia.spies@charite.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ERAS Doppler

Study hypothesis

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

Ethics Committee of Charité - University Medicine Berlin, approved on 4th December 2007

Study design

Prospective, randomised, double-blinded, two-arm multi-center trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colonic resection above the peritoneal reflection

Intervention

Targeted-volume application guided by esophageal doppler vs conventional volume application

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

05/02/2008

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant 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

Recruitment start date

05/02/2008

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Germany, Netherlands, Norway

Trial participating centre

Charitéplatz 1
Berlin
10117
Germany

Sponsor information

Organisation

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Sponsor details

Charitéplatz 1
Berlin
10117
Germany
anaesthesie-virchow-klinikum@charite.de

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

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

Publication citations

Additional files

Editorial Notes