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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01195883
First received: September 3, 2010
Last updated: April 14, 2014
Last verified: April 2014

September 3, 2010
April 14, 2014
November 2010
November 2014   (final data collection date for primary outcome measure)
Non-fatal postoperative complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Non-fatal postoperative complications within 30 days of surgery are reduced in patients receiving goal-directed colloid versus crystalloid fluid replacement intraoperatively
Same as current
Complete list of historical versions of study NCT01195883 on ClinicalTrials.gov Archive Site
  • Perfusion [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The effect of colloid versus crystalloid fluid replacement on complications differs by organ system. All-cause mortality is reduced when patients receive colloids intraoperatively.
Same as current
Not Provided
Not Provided
 
Effect of Goal- Directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
Not Provided

The investigators propose a prospective outcome study in which patients undergoing abdominal surgery will be randomized to receive either crystalloids or colloids intraoperatively guided by esophageal Doppler. The investigators will test the hypothesis that goal-directed colloid administration during elective abdominal surgery decreases postoperative complications more within 30 days after surgery as compared to goal-directed crystalloid administration.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Postoperative Complications
  • Other: Crystalloid

    All the 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]. For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. 9Patients will be randomized to:

    Group 1 (Crystalloid Group): In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ®, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm9 (see Figure 1), an additional fluid bolus of 250 ml of LR will be given over a time period of 5 minutes.

    Other Names:
    • Ringer's lactate
    • Lactaded Ringer's solution
  • Other: Colloid
    All the 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]. For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. 9Patients will be randomized to:Group 2 (Colloid Group): In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ®, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm9(see Figure 1), an additional fluid bolus of 250 ml of Hydroxyethylstarch 6% 130/0.4 (Voluven®Fresenius-Kabi, Bad Homburg, Germany) will be given over a time period of 5 minutes.
    Other Name: Voluven
  • Active Comparator: Crystalloid
    Lactated Ringers solution will be used for fluid replacement.
    Intervention: Other: Crystalloid
  • Active Comparator: Colloid
    low-molecular weight colloid HES 130/0.4 (Voluven)will be used for fluid replacement
    Intervention: Other: Colloid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1112
November 2014
November 2014   (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.
Both
18 Years to 80 Years
No
Contact: Roberta Johnson 216-444-9950 johnsor13@ccf.org
Contact: Andrea Kurz, MD 216-445-9924 ak@or.org
United States,   Austria
 
NCT01195883
09-1051
Yes
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Andrea Kurz, MD The Cleveland Clinic
The Cleveland Clinic
April 2014

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