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

Not Applicable

Completed

• Conditions: Reduction of Length of Hospitality Stay, Reduction of Perioperative Complications
• Interventions: Device: measurement of cardiac output and pulse pressure variation

• Registration Number: NCT01401283
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2015-12-01
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-06
• Last Update Submitted: 2016-01-06
• Results First Posted: 2016-02-05
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• major abdominal surgery
• duration of surgery > 2 hours

Exclusion Criteria

• age < 18 years
• scheduled postoperative icu treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	measurement of cardiac output and pulse pressure variation	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

Primary Outcome Measures

Name	Time	Method
Postoperative Complications	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

Name	Time	Method
Hospital Stay	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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany