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ISRCTN
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ISRCTN94786070
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ClinicalTrials.gov identifier
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Public title
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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)
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Scientific title
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Acronym
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ERAS Doppler
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Serial number at source
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N/A
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Study hypothesis
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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).
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Ethics approval
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Ethics Committee of Charité - University Medicine Berlin, approved on 4th December 2007
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Study design
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Prospective, randomised, double-blinded, two-arm multi-center trial
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Countries of recruitment
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Germany, Norway and the Netherlands
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Disease/condition/study domain
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Colonic resection above the peritoneal reflection
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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05/02/2008
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Anticipated end date
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01/02/2010
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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42
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Interventions
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Targeted-volume application guided by esophageal doppler vs conventional volume application
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Primary outcome measure(s)
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Difference in the amount of intravenously administered crystalloid and colloid fluid on the day of operation
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Secondary outcome measure(s)
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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.
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Sources of funding
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Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
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Trial website
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Publications
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Contact name
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Prof
Claudia
Spies
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Address
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Charitéplatz 1
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City/town
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Berlin
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Zip/Postcode
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10117
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Country
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Germany
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Email
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claudia.spies@charite.de
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Sponsor
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Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
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Address
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Charitéplatz 1
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City/town
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Berlin
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Zip/Postcode
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10117
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Country
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Germany
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Email
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anaesthesie-virchow-klinikum@charite.de
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Date applied
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04/02/2008
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Last edited
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27/03/2008
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Date ISRCTN assigned
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27/03/2008
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