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

Postoperative Complications Clinical Trial

— C-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195883
• Other study ID #: 09-1051
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: October 20, 2017

Study information

• Verified date: July 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1102
• Est. completion date: October 20, 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Drug:
• Crystalloid
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.
• Colloid
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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Cleveland Clinic Hillcrest Hospital	Mayfield Heights	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Countries where clinical trial is conducted

United States,  Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of Participants With Postoperative Acute Kidney Injury	Preoperative-to-postoperative change in AKIN stage	Hospitalization