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

Klinikum Ludwigshafen

Status and phase: Completed; Phase 4

Conditions: Major Abdominal Surgery

Treatments: Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine; Drug: Standard of care; Drug: Goal-directed hemodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00549419

2007-06

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

1

Experimental group

Description:

In the Treatment group, the traditional vital signs and APCO are made continuously available for fluid and catecholamine optimization and clinical decision making.

Treatment:

Drug: Goal-directed hemodynamic therapy

2

Active Comparator group

Treatment:

Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

Drug: Standard of care