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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01401283
First Posted: July 25, 2011
Last Update Posted: February 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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

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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]
    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 ]
    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, measurement of cardiac output and pulse pressure variation, hemodynamic optimization according to 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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 8, 2011
First Posted: July 25, 2011
Results First Submitted: December 1, 2015
Results First Posted: February 5, 2016
Last Update Posted: February 5, 2016
Last Verified: January 2016