Portal Vein Pulsatility Index to Assess Fluid Intolerance

NCT ID: NCT06440772

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-07-01

Brief Summary

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This study uses the portal vein pulsatility index (PVPI) to assess fluid intolerance amongst fluid responders.

Detailed Description

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This prospective observational study aims to use the portal vein pulsatility index (PVPI) to assess fluid intolerance in fluid responders. The investigators will enroll mechanically ventilated postoperative adult patients within 6 hours of ICU admission after cardiac surgery. Patients will undergo a Passive Leg Raising (PLR) test and Left Ventricular Outflow Tract (LVOT) recording using transthoracic echocardiography. The main objective is to predict fluid intolerance after a fluid challenge of 7 ml/kg Ringer Lactate over 10 minutes in initially tolerant fluid responders.

Conditions

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Venous Congestion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tolerant Fluid Responders

Patients who are both responsive and tolerant to fluid.

Ringer's Lactate Crystalloid Solutions

Intervention Type DRUG

7 ml/kg ml of Ringer's Lactate is given in 10 min amongst initially tolerant fluid responders.

Interventions

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Ringer's Lactate Crystalloid Solutions

7 ml/kg ml of Ringer's Lactate is given in 10 min amongst initially tolerant fluid responders.

Intervention Type DRUG

Other Intervention Names

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Fluid challenge

Eligibility Criteria

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Inclusion Criteria

* Informed consent.
* Mechanically ventilated patients within 6 hours after ICU admission following surgery who are considered for fluid administration to optimize haemodynamics.
* Sinus rhythm.

Exclusion Criteria

* A condition known to interfere with portal vein flow assessment or interpretation (liver cirrhosis or chronic hepatic disease, suprahepatic or portal vein thrombosis).
* Any mechanical circulatory support.
* Cardiac transplant.
* Poor transthoracic echocardiographic window.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

OTHER

Sponsor Role lead

Responsible Party

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Balan Ion Cosmin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cosmin Balan, PhD

Role: PRINCIPAL_INVESTIGATOR

"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Serban-Ion Bubenek-Turconi, Professor

Role: STUDY_CHAIR

"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Locations

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"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases

Bucharest, , Romania

Site Status

Countries

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Romania

References

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Balan C, Morosanu B, Fodoroiu A, Dobre V, Dumitrache A, Barbulescu RT, Valeanu L, Robu C, Boros C, Nica A, Wong A, Corradi F, Grintescu IM, Bubenek-Turconi SI. Decoding portal vein pulsatility: hemodynamic determinants in a post-hoc analysis of a prospective observational trial. Ann Intensive Care. 2025 Jun 14;15(1):81. doi: 10.1186/s13613-025-01498-0.

Reference Type DERIVED
PMID: 40515791 (View on PubMed)

Morosanu B, Balan C, Boros C, Dazzi F, Wong A, Corradi F, Bubenek-Turconi SI. Incidence, predictability, and outcomes of systemic venous congestion following a fluid challenge in initially fluid-tolerant preload-responders after cardiac surgery: a pilot trial. Crit Care. 2024 Oct 22;28(1):339. doi: 10.1186/s13054-024-05124-6.

Reference Type DERIVED
PMID: 39439007 (View on PubMed)

Other Identifiers

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6066/21.02.2023

Identifier Type: -

Identifier Source: org_study_id

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