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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 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
  Purpose
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.

Condition Intervention
Postoperative Complications
Drug: Crystalloid
Drug: Colloid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1112
Study Start Date: November 2010
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Crystalloid
Lactated Ringers solution will be used for fluid replacement.
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
Active Comparator: Colloid
Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195883

Contacts
Contact: Roberta Johnson 216-444-9950 johnsor13@ccf.org
Contact: Andrea Kurz, MD 216-445-9924 ak@or.org

Locations
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Roberta Johnson    216-444-9950    johnsor13@ccf.org   
Contact: Andrea Kurz, MD    216-445-9924    ak@or.org   
Cleveland Clinic Hillcrest Hospital Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Manal Hassan, MD    440-312-5259    hassanm@ccf.org   
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Barbara Kabon, MD    43-1-40400-4102    barbara.kabon@meduniwien.ac.at   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Andrea Kurz, MD The Cleveland Clinic
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01195883     History of Changes
Other Study ID Numbers: 09-1051 
Study First Received: September 3, 2010
Last Updated: June 6, 2016
Health Authority: United States: Institutional Review Board
Austria: Institutional Review Board

Keywords provided by The Cleveland Clinic:
IV fluid
recovery
goal directed fluid replacement
improved patient recovery

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on December 09, 2016