Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01195883
First received: September 3, 2010
Last updated: June 6, 2016
Last verified: June 2016

September 3, 2010
June 6, 2016
November 2010
November 2016   (final data collection date for primary outcome measure)
Postoperative morbidity (major complications) [ Time Frame: Postoperative 30-days ] [ Designated as safety issue: No ]
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 ] [ 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
Complete list of historical versions of study NCT01195883 on ClinicalTrials.gov Archive Site
  • Postoperative morbidity (minor complications) [ Time Frame: Postoperative 30-days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A composite of the primary outcome, and readmission and death.
  • Acute kidney injury [ Time Frame: Hospitalization ] [ Designated as safety issue: Yes ]
    Preoperative-to-postoperative change in AKIN stage
  • Tissue oxygenation [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    SF-36 scores. Measurements will be restricted to a sub-set of patients.
  • 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.
Not Provided
Not Provided
 
Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
Not Provided
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Complications
  • Drug: Crystalloid

    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. 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

    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. 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.
 
Recruiting
1112
November 2016
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.
Both
18 Years to 80 Years   (Adult, Senior)
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
Not Provided
Not Provided
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Andrea Kurz, MD The Cleveland Clinic
The Cleveland Clinic
June 2016

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