NCT04388995

Brief Summary

Although individualized or goal-directed approach has been advocated, a reliable index is still required to help monitor the volume status timely and efficiently. Dynamic indexes, such as pulse pressure variation (PPV) and stroke volume variation (SVV), have been shown to be clearly superior to more commonly measured static preload variables, such as pulmonary artery occlusion pressure (PAOP) and central venous pressure (CVP). The reliability of dynamic indexes in monitoring the volume status and predicting fluid responsiveness have been validated. Fluid optimization guided by SVV and PPV is beneficial to hemodynamic stability and can decrease mortality and reduce postoperative complications. However, the usefulness of dynamic indexes in elderly patients has not been previously investigated. This study aimed to evaluate whether dynamic indexes PPV and SVV can reliably predict fluid responsiveness in elderly patients, and to determine their thresholds in elderly patients.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 12, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

May 11, 2020

Last Update Submit

August 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fluid responsiveness

    Fluid responsiveness was defined as an increase in CI ≥15%

    immediately after the fluid therapy

Study Arms (1)

observed patients

EXPERIMENTAL
Diagnostic Test: volume expansion

Interventions

volume expansionDIAGNOSTIC_TEST

volume expansion with 6% hydroxyethyl starch (7 mL/kg) at a rate of 0.4 mL/kg/min

observed patients

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing gastrointestinal surgery 2.Age between 18 and 80 3.ASA I \~II. 4.BMI 18 \~ 24 kg/m2

You may not qualify if:

  • arrhythmias 2.intracardiac shunts 3.severe hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) 4.pulmonary hypertension 5.chronic obstructive pulmonary disease 6.peripheral vascular obstructive disease 7.receiving long-term treatment with vasopressors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Haidian, 100853, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 15, 2020

Study Start

May 12, 2020

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

August 26, 2020

Record last verified: 2020-08

Locations