Clinical trial NCT01195883: Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
Official title: Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Keywords: IV fluid
recovery
goal directed fluid replacement
improved patient recovery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2010-09-06
Enrollment: 1102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 hypothesis that goal-directed colloid administration during elective abdominal surgery decreases a composite of postoperative complications within 30 days of surgery.

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 weight \[Men: Ideal Body Weight (in kilograms) = 52 kg + 1.9 kg for every 2.5 cm over 150 cm; Women: Ideal Body Weight (in kilograms) = 49 kg + 1.7 kg for every 2.5 cm over 150 cm\].

They will then be randomly assigned to additional volume replacement, guided by esophageal Doppler, to either lactated Ringer's solution of Voluven starch.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Postoperative Morbidity (Major Complications)
timeFrame: Postoperative 30-days
Secondary outcomes:
measure: Number of Participants With Postoperative Morbidity (Minor Complications)
timeFrame: Postoperative 30-days
measure: Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death
timeFrame: Postoperative 30 days
measure: Number of Participants With Postoperative Acute Kidney Injury
timeFrame: Hospitalization
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Mayfield Heights
country: United States
facility: Cleveland Clinic Hillcrest Hospital
state: Ohio
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: The Cleveland Clinic
name: Andrea Kurz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reiterer C, Kabon B, Taschner A, Zotti O, Kurz A, Fleischmann E. A comparison of intraoperative goal-directed intravenous administration of crystalloid versus colloid solutions on the postoperative maximum N-terminal pro brain natriuretic peptide in patients undergoing moderate- to high-risk noncardiac surgery. BMC Anesthesiol. 2020 Aug 4;20(1):192. doi: 10.1186/s12871-020-01104-9.