Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Abdominal Surgery

Phase 4

Completed

• Conditions: Major Abdominal Surgery
• Interventions: Drug: Goal-directed hemodynamic therapy; Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine; Drug: Standard of care

• Registration Number: NCT00549419
• Lead Sponsor: Klinikum Ludwigshafen

Brief Summary

The purpose of this study is to determine whether the early identification and more precise intervention of goal-directed intraoperative plasma volume expansion and catecholamine therapy using arterial pressure based cardiac output (APCO) measurement in addition to normal vital signs will improve postoperative organ function, in particular renal function, in patients undergoing major abdominal surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-23
• Study First Submitted QC: 2007-10-24
• Study First Posted: 2007-10-25
• Status Verified: 2009-01
• Primary Completion: 2009-01
• Study Completion: 2009-04
• Last Update Submitted: 2009-12-21
• Last Update Posted: 2009-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patient is scheduled for elective major abdominal surgery and has two or more risk factors according to the Lee classification scheme.
• Patient can sign informed consent before surgery.
• Patient is able to comply with the study procedure.
• Patient must require an indwelling radial or a femoral artery catheter.
• Patient must be 20 years old or older.
• Patient must be 40kg or heavier.
• Patients height and weight can be accurately obtained prior to study start.

Exclusion Criteria

• Emergency surgery.
• Patients with aortic or mitral valve regurgitation.
• Renal insufficiency requiring hemodialysis.
• Liver dysfunction (alanine/aspartate aminotransferase >40 U/L).
• Patient with contraindications for the placement of radial, femoral or other arterial cannulae.
• Patient being treated with an intraaortic balloon pump.
• Female patients with a known pregnancy.
• Patient is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Goal-directed hemodynamic therapy	In the Treatment group, the traditional vital signs and APCO are made continuously available for fluid and catecholamine optimization and clinical decision making.
2	Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine	-
2	Standard of care	-

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate.	6 month

Secondary Outcome Measures

Name	Time	Method
Total fluid requirements (type and volume); Drug requirement (type and volume); Other organ function (myocardial function, liver function, endothelial function, degree of inflammation)	6 month

Trial Locations

Locations (1)

Klinikum Ludwigshafen; 🇩🇪 Ludwigshafen, RLP, Germany