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

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Crystalloid
Colloid
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complications focused on measuring IV fluid, recovery, goal directed fluid replacement, improved patient recovery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cleveland Clinic Foundation
  • Cleveland Clinic Hillcrest Hospital
  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Crystalloid

Colloid

Arm Description

Lactated Ringers solution will be used for fluid replacement.

Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement

Outcomes

Primary Outcome Measures

Number of Participants With Postoperative Morbidity (Major Complications)
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

Number of Participants With Postoperative Morbidity (Minor Complications)
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.
Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death
A composite of the primary outcome, and readmission and death.
Number of Participants With Postoperative Acute Kidney Injury
Preoperative-to-postoperative change in AKIN stage

Full Information

First Posted
September 3, 2010
Last Updated
October 1, 2018
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01195883
Brief Title
Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
Acronym
C-C
Official Title
Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
October 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
IV fluid, recovery, goal directed fluid replacement, improved patient recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crystalloid
Arm Type
Active Comparator
Arm Description
Lactated Ringers solution will be used for fluid replacement.
Arm Title
Colloid
Arm Type
Active Comparator
Arm Description
Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement
Intervention Type
Drug
Intervention Name(s)
Crystalloid
Other Intervention Name(s)
Ringer's lactate, Lactated Ringer's solution
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Colloid
Other Intervention Name(s)
Voluven
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Postoperative Morbidity (Major Complications)
Description
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).
Time Frame
Postoperative 30-days
Secondary Outcome Measure Information:
Title
Number of Participants With Postoperative Morbidity (Minor Complications)
Description
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.
Time Frame
Postoperative 30-days
Title
Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death
Description
A composite of the primary outcome, and readmission and death.
Time Frame
Postoperative 30 days
Title
Number of Participants With Postoperative Acute Kidney Injury
Description
Preoperative-to-postoperative change in AKIN stage
Time Frame
Hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Kurz, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cleveland Clinic Hillcrest Hospital
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32753064
Citation
Reiterer C, Kabon B, Taschner A, Zotti O, Kurz A, Fleischmann E. A comparison of intraoperative goal-directed intravenous administration of crystalloid versus colloid solutions on the postoperative maximum N-terminal pro brain natriuretic peptide in patients undergoing moderate- to high-risk noncardiac surgery. BMC Anesthesiol. 2020 Aug 4;20(1):192. doi: 10.1186/s12871-020-01104-9.
Results Reference
derived

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

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