NCT03089710

Brief Summary

Perioperative fluid management is crucial for patients' outcome. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in prone position surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

March 31, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2018

Completed
Last Updated

February 11, 2020

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

February 22, 2017

Last Update Submit

February 9, 2020

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Change of cardiac index after fluid loading

    interpretate the correlation of mini-fluid challenge and conventional fluid challenge

    3hr

Secondary Outcomes (1)

  • pulse pressure variation(PPV)

    3hr

Other Outcomes (2)

  • stroke volume variation(SVV)

    3hr

  • plethysmographic variation index(PVI)

    3hr

Study Arms (1)

Mini-Fluid Challenge arm

EXPERIMENTAL

Fluid challenge test will be presented after induction of anesthesia at a steady state. Fluid challenge test includes 2 components: 100 ml colloid infusion in 1 min followed by 400 ml colloid infusion in 14 mins. Hemodynamic parameter after 1 minute of the end of the 1st and 2nd colloid infusion bolus will be collected. Applied colloid: hydroxyethyl starch

Other: Mini-fluid challenge

Interventions

Mini-fluid challengeOTHER

Mini-fluid challenge test with 100mL colloid infusion in 1 min

Mini-Fluid Challenge arm

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving scheduled prone position spine surgery
  • BMI 18.5\~30 kg.m-2

You may not qualify if:

  • age younger then 20 yrs or elder than 80 yrs
  • pregnant women
  • patients in intensive care units
  • patients with the underlying disease including respiratory failure(FEV1/FVC \< 70 % and FEV1 \< 50%), heart failure(NYHA score =III、IV), kidney failure(eGFR\< 60 ml.min-1.1.73m-2), liver failure
  • patients with ongoing infection
  • patients allergic to voluven

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University

Taipei, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2017

First Posted

March 24, 2017

Study Start

March 31, 2017

Primary Completion

September 14, 2018

Study Completion

September 14, 2018

Last Updated

February 11, 2020

Record last verified: 2018-10

Locations

TW(1)