Status:
COMPLETED
Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
Lead Sponsor:
The Cleveland Clinic
Conditions:
Postoperative Complications
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 hyp...
Detailed Description
Patients will be given 5-7 ml/kg of crystalloid (lactated Ringer's) in the immediate preoperative period, which will be followed by 4 ml/kg/h crystalloid for maintenance normalized to ideal body weigh...
Eligibility Criteria
Inclusion
- ASA Physical Status 1-3
- Body Mass Index \< 35
- Moderate risk elective abdominal surgical procedures scheduled to take ≥ two hours done under general anesthesia.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2017
Estimated Enrollment :
1102 Patients enrolled
Trial Details
Trial ID
NCT01195883
Start Date
November 1 2010
End Date
October 20 2017
Last Update
October 30 2018
Active Locations (3)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
2
Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
3
Medical University of Vienna
Vienna, Austria, 1090