NCT04030221

Brief Summary

Surgical patients, especially those with insufficient blood volume and hypotension, often need fluid therapy. However, there is still a lack of simple and reliable indicators for judging transfusion responsiveness in some types of surgery. Previous studies have shown that Pressure Gradient for Venous Return (PVR) can be used to guide infusion. Thus, our aim is to explore the relationship between PVR and liquid reactivity.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 19, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

July 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

1 month

First QC Date

July 19, 2019

Last Update Submit

July 19, 2019

Conditions

Fluid Responsiveness

Keywords

the pressure gradient for venous returnfluid responsiveness

Outcome Measures

Primary Outcomes (1)

  • hemodynamic parameters

    direct arterial pressure including systolic, diastolic and mean arterial pressure; central venous pressure.These data are collected continuously and dynamically.

    At enrollment

Interventions

fluid infusionOTHER

250 ml of liquid will be given within 10 minutes for each patients, and the hemodynamic parameters before and after fluid infusion will be recorded. Then the experiment is completed.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing laparoscopic surgery and general anesthesia

You may qualify if:

  • patients undergoing laparoscopic surgery and general anesthesia

You may not qualify if:

  • cardiac insufficiency; severe arrhythmias; patients using intra-aortic balloon pump; use of left ventricular assist devices; spasm of peripheral arteries caused by some factor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Study Officials

  • Yan Min, Doctor

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    STUDY DIRECTOR

Central Study Contacts

Yan Min, Doctor

CONTACT

+86-13757118632zryanmin@ziu.edu.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 23, 2019

Study Start

July 20, 2019

Primary Completion

August 20, 2019

Study Completion

August 20, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

CN(1)