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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Complications

Intervention / Treatment
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* Drug: Crystalloid
* Drug: Colloid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Crystalloid<br>Lactated Ringers solution will be used for fluid replacement. | Drug: Crystalloid<br>* 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.<br>* Other names: Lactated Ringer's solution;|
| Active Comparator: Colloid<br>Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement | Drug: Colloid<br>* 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.<br>* Other names: Voluven;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Postoperative Morbidity (Major Complications) | 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 30-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Postoperative Morbidity (Minor Complications) | 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. | Postoperative 30-days | 
| Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death | A composite of the primary outcome, and readmission and death. | Postoperative 30 days | 
| Number of Participants With Postoperative Acute Kidney Injury | Preoperative-to-postoperative change in AKIN stage | Hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV fluid, recovery, goal directed fluid replacement, improved patient recovery