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Goal Directed Fluid Management Based on Non-invasive Monitoring

Primary Purpose

Postoperative Complication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Goal-directed Therapy group
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complication focused on measuring Goal-directed fluid therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Patients (male or female)
  • Over 18 years old undergoing non-cardiac surgery
  • Weight > 40 kg, Body Mass Index < 40

Exclusion Criteria:

  • Patients who do not consent
  • Body Mass Index > 40

Sites / Locations

  • University of California, Irvine Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Goal-directed Therapy group

Arm Description

Baseline crystalloid infusion of 5 mL/kg/hr of body weight.

Goal-direct therapy

Outcomes

Primary Outcome Measures

Duration of hospital stay
The length of stay in the hospital is defined as postoperative number of days in the hospital until discharge.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2012
Last Updated
February 9, 2016
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT01883752
Brief Title
Goal Directed Fluid Management Based on Non-invasive Monitoring
Official Title
Goal-Directed Fluid Management Based on Non- Invasive Monitoring of Pulse Oximeter-Derived Pleth Variability Index
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether goal directed fluid management using respiratory variations in the oxygen saturation by pulse oximetry (SpO2) waveform has potential to decrease postoperative complications and outcomes.
Detailed Description
The aim of this study is to test the hypothesis that monitoring and minimizing the respiratory variations in the pulse oximeter waveform amplitude by volume loading has potential to decrease postoperative morbidity and length of stay in the hospital in patients undergoing routine, moderate-risk elective surgery. In this study the investigators will test the impact of hemodynamic optimization based on the respiratory variations in the plethysmographic waveform amplitude to decrease postoperative morbidity and length of stay in the hospital in patients undergoing routine, moderate-risk elective surgery. The primary outcome variable is the incidence of postoperative complications. Secondary outcome variables are the duration of hospital and ICU stays, postoperative mortality, and cost of surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complication
Keywords
Goal-directed fluid therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Baseline crystalloid infusion of 5 mL/kg/hr of body weight.
Arm Title
Goal-directed Therapy group
Arm Type
Experimental
Arm Description
Goal-direct therapy
Intervention Type
Procedure
Intervention Name(s)
Goal-directed Therapy group
Other Intervention Name(s)
Goal Directed Fluid Optimization group
Intervention Description
Fluid administration is based on the respiratory variation in the pulse oximeter waveform
Primary Outcome Measure Information:
Title
Duration of hospital stay
Description
The length of stay in the hospital is defined as postoperative number of days in the hospital until discharge.
Time Frame
Maximum 90 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients (male or female) Over 18 years old undergoing non-cardiac surgery Weight > 40 kg, Body Mass Index < 40 Exclusion Criteria: Patients who do not consent Body Mass Index > 40
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxime Cannesson, MD, PhD
Organizational Affiliation
UC Irvine Medical Center, Dept of Anesthesiology & Perioperative Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10439777
Citation
Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050.
Results Reference
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PubMed Identifier
8201106
Citation
Mythen MG, Webb AR. Intra-operative gut mucosal hypoperfusion is associated with increased post-operative complications and cost. Intensive Care Med. 1994;20(2):99-104. doi: 10.1007/BF01707662.
Results Reference
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PubMed Identifier
18813052
Citation
Chappell D, Jacob M, Hofmann-Kiefer K, Conzen P, Rehm M. A rational approach to perioperative fluid management. Anesthesiology. 2008 Oct;109(4):723-40. doi: 10.1097/ALN.0b013e3181863117.
Results Reference
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PubMed Identifier
15281524
Citation
Lebuffe G, Vallet B, Takala J, Hartstein G, Lamy M, Mythen M, Bakker J, Bennett D, Boyd O, Webb A. A european, multicenter, observational study to assess the value of gastric-to-end tidal PCO2 difference in predicting postoperative complications. Anesth Analg. 2004 Jul;99(1):166-72. doi: 10.1097/00000539-200407000-00034.
Results Reference
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PubMed Identifier
9361539
Citation
Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. doi: 10.1136/bmj.315.7113.909.
Results Reference
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PubMed Identifier
11881887
Citation
Venn R, Steele A, Richardson P, Poloniecki J, Grounds M, Newman P. Randomized controlled trial to investigate influence of the fluid challenge on duration of hospital stay and perioperative morbidity in patients with hip fractures. Br J Anaesth. 2002 Jan;88(1):65-71. doi: 10.1093/bja/88.1.65.
Results Reference
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PubMed Identifier
16155038
Citation
Wakeling HG, McFall MR, Jenkins CS, Woods WG, Miles WF, Barclay GR, Fleming SC. Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005 Nov;95(5):634-42. doi: 10.1093/bja/aei223. Epub 2005 Sep 9.
Results Reference
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PubMed Identifier
12357146
Citation
Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
Results Reference
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PubMed Identifier
12190747
Citation
Conway DH, Mayall R, Abdul-Latif MS, Gilligan S, Tackaberry C. Randomised controlled trial investigating the influence of intravenous fluid titration using oesophageal Doppler monitoring during bowel surgery. Anaesthesia. 2002 Sep;57(9):845-9. doi: 10.1046/j.1365-2044.2002.02708.x.
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PubMed Identifier
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Citation
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Results Reference
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Goal Directed Fluid Management Based on Non-invasive Monitoring

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