NCT01950949

Brief Summary

Mesquida, J et al showed there was a significant linear correlation between pulse pressure variations under tidal volume 6 ml/kg and 8 ml/kg in patients after the resuscitation phase of severe sepsis and septic shock. No study revealed the actual relationship between various PPV under different VT. So we hypothesized that there were relationship between various PPV in different tidal volume settings. The objective of this study was to examine the relationship between various PPV.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

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

July 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 26, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

1.7 years

First QC Date

July 26, 2013

Last Update Submit

September 17, 2015

Conditions

Respiration, Artificial

Outcome Measures

Primary Outcomes (1)

  • invasive arterial blood pressure as a Measure of Safety

    if instability of circulation, stop the clinical trial

    Day 1

Study Arms (1)

change respiratory parameters, volume expanding

EXPERIMENTAL
Other: 300 ml Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection infusing in 15 minutes if PPV under VT 8 ml/kg was larger than 13% in the initial investigation

Interventions

300 ml Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection infusing in 15 minutes if PPV under VT 8 ml/kg was larger than 13% in the initial investigationOTHER
change respiratory parameters, volume expanding

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • scheduled for elective abdominal surgeries ASA (American Society of Anesthesiologists) I or II BMI 18-25 preoperative examination is normal

You may not qualify if:

  • acute lung injure acute respiratory distress syndrome cardiovascular diseases neurological disease renal or hepatic disease diabetes mellitus BMI less than 18 kg/m2 or greater than 25 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Liu Y, Lou JS, Mi WD, Yuan WX, Fu Q, Wang M, Qu J. Pulse pressure variation shows a direct linear correlation with tidal volume in anesthetized healthy patients. BMC Anesthesiol. 2016 Sep 8;16:75. doi: 10.1186/s12871-016-0233-y.

    PMID: 27609188DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Hydroxyethyl Starch Derivatives

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending of AOC

Study Record Dates

First Submitted

July 26, 2013

First Posted

September 26, 2013

Study Start

July 1, 2012

Primary Completion

March 1, 2014

Study Completion

May 1, 2015

Last Updated

September 18, 2015

Record last verified: 2015-09