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

NCT01195883 | Completed Results DMC

• 1 other identifier: 09-1051
• Study Type: interventional
• Target: 1,102
• Locations: 2 countries
• Sites: 3

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.

Conditions

Postoperative Complications

Keywords

IV fluid; recovery; goal directed fluid replacement; improved patient recovery

Outcome Measures

Primary Outcomes (1)

• 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).

  Postoperative 30-days

Secondary Outcomes (3)

• Number of Participants With Postoperative Morbidity (Minor Complications)

  Postoperative 30-days

• Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death

  Postoperative 30 days

• Number of Participants With Postoperative Acute Kidney Injury

  Hospitalization

Study Arms (2)

Crystalloid

ACTIVE COMPARATOR

Lactated Ringers solution will be used for fluid replacement.

Drug: Crystalloid

Colloid

ACTIVE COMPARATOR

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

Drug: Colloid

Interventions

Crystalloid DRUG

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.

Also known as: Ringer's lactate, Lactated Ringer's solution

Crystalloid

Colloid DRUG

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.

Also known as: Voluven

Colloid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA Physical Status 1-3
• Body Mass Index \< 35
• Moderate risk elective abdominal surgical procedures scheduled to take ≥ two hours done under general anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (3)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Cleveland Clinic Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 32753064 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Crystalloid Solutions; Ringer's Lactate; Colloids; HES 130-0.4

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations; Complex Mixtures; Dosage Forms

Results Point of Contact

• Title: Daniel I. Sessler, MD
• Organization: Cleveland Clinic

DS@OR.org

216-444-4900

Study Officials

• Andrea Kurz, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 6, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2016
• Study Completion: October 20, 2017
• Last Updated: October 30, 2018
• Results First Posted: August 21, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); AU (1)