GDT by Cardiac Index Trending Via a Radial Arterial Line in General Surgery

This study has been completed.
Sponsor:
Collaborators:
Northern State Medical University
Szeged University
University of Kiel
University of Witten/Herdecke
University of Valencia
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01401283
First received: July 8, 2011
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients Clinical outcome of patients undergoing major abdominal surgery is explored in two different groups. In one group hemodynamic management is guided by the internal standard of the anesthesiological department. In the other group fluid management is goal directed by by continuous cardiac index trending via a radial arterial line and pulse pressure variation.


Condition Intervention
Reduction of Length of Hospitality Stay, Reduction of Perioperative Complications
Device: measurement of cardiac output and pulse pressure variation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Multi-center, Prospective, Randomized Outcome Study Comparing Continuous Cardiac Index Trending Via a Radial Arterial Line Versus Standard Care in General Surgical Patients

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • postoperative complications [ Time Frame: Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days ] [ Designated as safety issue: No ]
    Categories of postoperative complications: Infection (respiratory, abdominal, UTI, wound), Respiratory (prolonged need for ventilation), Cardiovascular (edema, arrythmia, hypotension, AMI, stroke), Abdominal (constipation), Renal (urine output <500ml/d, ARF)


Secondary Outcome Measures:
  • hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ] [ Designated as safety issue: No ]
    length of stay in the postoperative care unit, length of hospital stay


Enrollment: 160
Study Start Date: July 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Study group
intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation
Device: measurement of cardiac output and pulse pressure variation
hemodynamic optimization according to cardiac index and pulse pressure variation
No Intervention: Control group
hemodynamic management according to institutional clinical standards

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • major abdominal surgery
  • duration of surgery > 2 hours

Exclusion Criteria:

  • age < 18 years
  • scheduled postoperative icu treatment
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01401283

Locations
Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20251
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Northern State Medical University
Szeged University
University of Kiel
University of Witten/Herdecke
University of Valencia
Investigators
Principal Investigator: Daniel A Reuter, MD Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided by Universitätsklinikum Hamburg-Eppendorf

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01401283     History of Changes
Other Study ID Numbers: 797726
Study First Received: July 8, 2011
Last Updated: November 2, 2012
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on September 16, 2014