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Completed

NCT Number: NCT00549419

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

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.

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Key information

Conditions

Major Abdominal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinikum Ludwigshafen

Ludwigshafen, RLP, 67063, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

Drug

The Control group will be assessed using the standard care of traditional vital signs

Goal-directed hemodynamic therapy

Drug

Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

Standard of care

Drug

Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

Primary outcomes

  1. The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate.

    Time frame: 6 month

Secondary outcomes

  1. Total fluid requirements (type and volume); Drug requirement (type and volume); Other organ function (myocardial function, liver function, endothelial function, degree of inflammation)

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Klinikum Ludwigshafen

Other

Registry information

Official study title

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

Acronym: REPEAT

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 25, 2007
Registry last updated
Dec 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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