Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity (C-C)
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|ClinicalTrials.gov Identifier: NCT01195883|
Recruitment Status : Completed
First Posted : September 6, 2010
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Complications||Drug: Crystalloid Drug: Colloid||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||October 20, 2017|
Active Comparator: Crystalloid
Lactated Ringers solution will be used for fluid replacement.
For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of LR will be given over a period of 5 minutes.
Active Comparator: Colloid
Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement
For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of Hydroxyethylstarch 6% 130/0.4 (Voluven®Fresenius-Kabi, Bad Homburg, Germany) will be given over a period of 5 minutes.
Other Name: Voluven
- Postoperative morbidity (major complications) [ Time Frame: Postoperative 30-days ]Any of the following major complications: (1) Cardiac (Acute heart failure/Myocardial infarction/Ventricular arrhythmia); (2) pulmonary (embolism/edema/respiratory failure/pneumonia/pleural effusion); (3) gastrointestinal (bowel and surgical anastomosis stricture or anastomotic leak/internal or external fistulas/peritoneal effusions); (4) Renal (requiring dialysis); (5) Infectious (deep or organ space surgical site infection / sepsis); and (6) Coagulation (bleeding).
- Postoperative morbidity (minor complications) [ Time Frame: Postoperative 30-days ]Any of the following minor complications: (1) unplanned ICU admission; (2) unplanned operation; (3) cardiac (ischemia/non-ventricular arrhythmia/hemodynamic disturbances); (4) pulmonary effusion; (5) deep venous thrombosis; (6) gastrointestinal (effusion/gut paralysis); (7) progressive renal insufficiency; (8) infection (superficial/fever/cystitis or urinary tract infection); and (9) transient neurological injury.
- Major complications, readmission, and death [ Time Frame: Postoperative 30 days ]A composite of the primary outcome, and readmission and death.
- Acute kidney injury [ Time Frame: Hospitalization ]Preoperative-to-postoperative change in AKIN stage
- Tissue oxygenation [ Time Frame: Intraoperative ]Muscle oxygen saturation and gut oxygen partial pressure. Measurements will be restricted to a sub-set of patients.
- Functional recovery [ Time Frame: Postoperative 30 days ]SF-36 scores. Measurements will be restricted to a sub-set of patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195883
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Cleveland Clinic Hillcrest Hospital|
|Mayfield Heights, Ohio, United States, 44124|
|Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Andrea Kurz, MD||The Cleveland Clinic|