Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity

Completed · Not applicable

Conditions studied: Postoperative Complications

In brief

A trial in which patients having open abdominal surgery are randomized to receive either crystalloids or colloids intraoperatively, guided by esophageal Doppler. The investigators test the primary hypothesis that goal-directed colloid administration during elective abdominal surgery decreases a composite of postoperative complications within 30 days of surgery.

Key facts

Study ID

NCT01195883

Run by

The Cleveland Clinic

People needed

1102

Starts

2010-11-01

Expected to finish

2017-10-20

Last updated by the study team

2018-10-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ASA Physical Status 1-3
• Body Mass Index < 35
• Moderate risk elective abdominal surgical procedures scheduled to take ≥ two hours done under general anesthesia.

You may not qualify if…

• cardiac insufficiency (EF<35%)
• coronary disease with angina (NYHA IV)
• severe chronic obstructive pulmonary disease
• coagulopathies
• symptoms of infection or sepsis
• renal insufficiency (creatinine clearance <30ml/min or renal replacement therapy)
• ASA Physical Status > 3.

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Cleveland Clinic Hillcrest Hospital — Mayfield Heights, Ohio, United States
• Medical University of Vienna — Vienna, Austria

Full record on ClinicalTrials.gov

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