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
  Purpose

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.


Condition Intervention
Postoperative Complications
Other: Crystalloid
Other: Colloid

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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1112
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Crystalloid
Lactated Ringers solution will be used for fluid replacement.
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
Active Comparator: Colloid
low-molecular weight colloid HES 130/0.4 (Voluven)will be used for fluid replacement
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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   
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

No publications provided

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: April 14, 2014
Health Authority: United States: 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 September 18, 2014