Goal Directed Fluid Management Based on Non-invasive Monitoring

NCT01883752 | Completed DMC

• 1 other identifier: UCIANES01
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complication

Keywords

Goal-directed fluid therapy

Outcome Measures

Primary Outcomes (1)

• Duration of hospital stay

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

  Maximum 90 days after surgery

Study Arms (2)

Control

NO INTERVENTION

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

Goal-directed Therapy group

EXPERIMENTAL

Goal-direct therapy

Procedure: Goal-directed Therapy group

Interventions

Goal-directed Therapy group PROCEDURE

Fluid administration is based on the respiratory variation in the pulse oximeter waveform

Also known as: Goal Directed Fluid Optimization group

Goal-directed Therapy group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (10)

• 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.

  PMID: 10439777 BACKGROUND

• 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.

  PMID: 8201106 BACKGROUND

• 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.

  PMID: 18813052 BACKGROUND

• 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.

  PMID: 15281524 BACKGROUND

• 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.

  PMID: 9361539 BACKGROUND

• 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.

  PMID: 11881887 BACKGROUND

• 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.

  PMID: 16155038 BACKGROUND

• 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.

  PMID: 12357146 BACKGROUND

• 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.

  PMID: 12190747 BACKGROUND

• Poeze M, Greve JW, Ramsay G. Meta-analysis of hemodynamic optimization: relationship to methodological quality. Crit Care. 2005;9(6):R771-9. doi: 10.1186/cc3902. Epub 2005 Nov 15.

  PMID: 16356226 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maxime Cannesson, MD, PhD

  UC Irvine Medical Center, Dept of Anesthesiology & Perioperative Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: June 21, 2013
• Study Start: July 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

US (1)