NCT05944146

Brief Summary

Currently, the gold standard method to estimate CO is the thermodilution technique, pulmonary artery catheter (PAC) and PiCCO system included, however, the invasiveness and complexity of the thermodilution technique have limited their usefulness in many clinical scenarios. By measuring the carotid blood flow, continuous carotid doppler technique has been reported to noninvasively estimate cardiac output (CO) and other parameters related to cardiac contractility and fluid status in various cardiovascular disorders. However, to the best of our knowledge, few study has been reported to evaluate the consistency of this technique in cardiac surgery patients. The aim of this study is to evaluate the tracking ability of CO changes measured by continuous carotid doppler technique in cardiac surgery patients, use the thermodilution technique as the referenced.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress82%
May 2023Dec 2026

Study Start

First participant enrolled

May 31, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

3.6 years

First QC Date

July 5, 2023

Last Update Submit

July 12, 2023

Conditions

Cardiac Surgery

Keywords

carotid doppler; hemodynamic

Outcome Measures

Primary Outcomes (8)

  • cardiac output by thermodilution method

    measuring cardiac output using thermodilution method

    5 minutes after the patients was sedated

  • cardiac output by continuous carotid doppler blood flow

    measuring cardiac output using continuous carotid doppler blood flow

    5minutes after the patients was sedated

  • cardiac output by thermodilution method

    measuring cardiac output using thermodilution method

    2 minutes after passive leg raising

  • cardiac output by continuous carotid doppler blood flow

    measuring cardiac output using continuous carotid doppler blood flow

    2 minutes after passive leg raising

  • cardiac output by thermodilution method

    measuring cardiac output using thermodilution method

    15 minutes after termination of passive leg raising

  • cardiac output by continuous carotid doppler blood flow

    measuring cardiac output using continuous carotid doppler blood flow

    15 minutes after termination of passive leg raising

  • cardiac output by thermodilution method

    measuring cardiac output using thermodilution method

    30 minutes after dobutamine infusion

  • cardiac output by continuous carotid doppler blood flow

    measuring cardiac output using continuous carotid doppler blood flow

    30 minutes after dobutamine infusion

Study Arms (1)

cardiac surgery patients with thermodilution technique monitoring

EXPERIMENTAL
Behavioral: passive leg raisingDrug: Dobutamine

Interventions

passive leg raisingBEHAVIORAL

transfer a patient from semi-recumbent position to supine position with a 45° leg lifting

cardiac surgery patients with thermodilution technique monitoring
DobutamineDRUG

infusion dobutamine

cardiac surgery patients with thermodilution technique monitoring

Eligibility Criteria

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

You may qualify if:

  • adult cardiac surgery patients
  • with thermodilution technique monitoring
  • mechanical ventilation

You may not qualify if:

  • life threatening arrhythmia
  • severe valve regurgitation
  • left ventricular ejection fraction less than 30%
  • patients with mechanical circulatory support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Interventions

Dobutamine

Intervention Hierarchy (Ancestors)

CatecholaminesAminesOrganic ChemicalsPhenethylaminesEthylaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Zhe Luo

    Fudan University

    STUDY CHAIR

Central Study Contacts

Guang-wei Hao

CONTACT

02164041990hao.guangwei@zs-hospital.sh.cn

Guo-wei Tu

CONTACT

02164041990tu.guowei@zs-hospital.sh.cn

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

July 5, 2023

First Posted

July 13, 2023

Study Start

May 31, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 13, 2023

Record last verified: 2023-07

Locations

CN(1)