NCT01402934

Brief Summary

The investigators hypothesized that pulse pressure variation (PPV) could predict fluid responsiveness in spontaneously breathing patients undergoing anesthesia induction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

May 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

April 21, 2016

Status Verified

July 1, 2011

Enrollment Period

4 months

First QC Date

May 29, 2011

Last Update Submit

April 20, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • pulse pressure variation

    three respiratory cycles, an expected average of 30 seconds

Secondary Outcomes (1)

  • hemodynamic parameters

    before and after fluid loading, 1 mimute

Study Arms (1)

fluid infusion

EXPERIMENTAL
Procedure: Hydroxyethyl starch solution (Voluven) infusion

Interventions

fluid loading will be performed by hydroxyethyl starch solution (Voluven), at 6 mL/kg

fluid infusion

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing thoracic surgery

You may not qualify if:

  • preoperative arrhythmia
  • left ventricular ejection fraction \<40%
  • intra-cardiac valve disease
  • intra-cardiac shunt
  • pulmonary artery hypertension
  • severe peripheral vascular obstructive disease
  • decreased pulmonary function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

HES 130-0.4

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 29, 2011

First Posted

July 26, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

April 21, 2016

Record last verified: 2011-07

Locations