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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01195883
First Posted: September 6, 2010
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Cleveland Clinic
September 3, 2010
September 6, 2010
September 25, 2017
November 2010
November 2016   (Final data collection date for primary outcome measure)
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).
Non-fatal postoperative complications [ Time Frame: 30 days ]
Non-fatal postoperative complications within 30 days of surgery are reduced in patients receiving goal-directed colloid versus crystalloid fluid replacement intraoperatively
Complete list of historical versions of study NCT01195883 on ClinicalTrials.gov Archive Site
  • 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.
  • Perfusion [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively.
  • Oxygenation [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively.
  • collagen [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively.
  • Orthogonal polarization spectral (OPS) imaging [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively.
  • cardiac function [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively.
  • renal function [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively
  • Post Operative Nausea and Vomiting (PONV) [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively.
  • pain [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively
  • return to function [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively.
  • ICU Admission [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively.
  • duration of ICU stay [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively.
  • duration of mechanical ventilation [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively.
  • duration of hospitalization [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively.
  • readmission [ Time Frame: 30 days ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively.
Not Provided
Not Provided
 
Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Complications
  • 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.
    Other Names:
    • Ringer's lactate
    • Lactated Ringer's solution
  • Drug: 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.
    Other Name: Voluven
  • Active Comparator: Crystalloid
    Lactated Ringers solution will be used for fluid replacement.
    Intervention: Drug: Crystalloid
  • Active Comparator: Colloid
    Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement
    Intervention: Drug: Colloid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1112
October 2017
November 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   United States
 
 
NCT01195883
09-1051
Yes
Not Provided
Plan to Share IPD: No
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Andrea Kurz, MD The Cleveland Clinic
The Cleveland Clinic
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP