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

Major Abdominal Surgery Clinical Trial

— REPEAT  

Official title:

Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Patients Undergoing Major Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549419
• Other study ID #: 2007-06
• Status: Completed
• Phase: Phase 4
• First received: October 23, 2007
• Last updated: December 21, 2009
• Start date: October 2007
• Est. completion date: April 2009

Study information

• Verified date: January 2009
• Source: Klinikum Ludwigshafen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Major Abdominal Surgery

Intervention

Drug:
• Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine
The Control group will be assessed using the standard care of traditional vital signs
• Goal-directed hemodynamic therapy
Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine
• Standard of care
Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

Locations

Country	Name	City	State
Germany	Klinikum Ludwigshafen	Ludwigshafen	RLP

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Ludwigshafen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate.		6 month	No
Secondary	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	No