NCT07397663

Brief Summary

This prospective observational study aims to evaluate the ability of transthoracic echocardiographic and bedside ultrasonographic parameters to predict intradialytic hypotension and hemodynamic instability at the initiation of continuous venovenous hemodiafiltration (CVVHDF) in adult intensive care unit patients.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Feb 2026

Shorter than P25 for all trials

Status
not yet 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 Progress24%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

February 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 2, 2026

Last Update Submit

February 11, 2026

Conditions

Renal Failure , ChronicIntradialytic HypotensionCritical Illness

Keywords

Intradialytic HypotensionLVOT VTICVVHDRenal Resistive IndexEchocardiographyVExUS

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic Instability During CVVHDF Initiation

    Occurrence of hypotension (mean arterial pressure \<65 mmHg), requirement for fluid bolus (≥500 mL), or initiation/increase of vasopressor or inotrope support within the first 60 minutes after CVVHDF initiation.

    First 60 minutes after CVVHDF initiation

Secondary Outcomes (7)

  • LVOT Velocity Time Integral

    Before CVVHDF initiation

  • Mitral Annular Plane Systolic Excursion (MAPSE)

    Before CVVHDF initiation

  • Tricuspid Annular Plane Systolic Excursion (TAPSE)

    Before CVVHDF initiation

  • Pulse Pressure Variation (PPV)

    Before CVVHDF initiation

  • Renal Resistive Index (RRI)

    Before CVVHDF initiation

  • +2 more secondary outcomes

Eligibility Criteria

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

The study population consists of adult patients (aged 18 years and older) admitted to the intensive care unit of a tertiary care academic hospital who have a clinical indication for continuous venovenous hemodiafiltration (CVVHDF). All participants are critically ill and require renal replacement therapy as part of standard clinical care. Transthoracic echocardiography and bedside ultrasonographic and hemodynamic assessments are performed as part of routine intensive care evaluation and are recorded for observational purposes only. No healthy volunteers are included in this study. Written informed consent is obtained from the patients' legal representatives prior to study inclusion.

You may qualify if:

  • Adult patients (≥18 years) admitted to the intensive care unit
  • Indication for continuous venovenous hemodiafiltration
  • Adequate transthoracic echocardiographic image quality
  • Written informed consent obtained from legal representatives

You may not qualify if:

  • Acute coronary syndrome
  • Severe valvular heart disease or pericardial effusion
  • Significant arrhythmias interfering with Doppler measurements
  • Presence of pacemaker, ICD, or ventricular assist device
  • Poor echocardiographic imaging window
  • Life expectancy less than 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Cheong I. Unconventional Echocardiographic Techniques for LVOT VTI Measurement in Critical Care Settings. J Clin Ultrasound. 2025 Jul-Aug;53(6):1418-1424. doi: 10.1002/jcu.24007. Epub 2025 Apr 12.

    PMID: 40219729BACKGROUND

  • Assavapokee T, Rola P, Assavapokee N, Koratala A. Decoding VExUS: a practical guide for excelling in point-of-care ultrasound assessment of venous congestion. Ultrasound J. 2024 Nov 19;16(1):48. doi: 10.1186/s13089-024-00396-z.

    PMID: 39560910BACKGROUND

  • Monnet X, Shi R, Teboul JL. Prediction of fluid responsiveness. What's new? Ann Intensive Care. 2022 May 28;12(1):46. doi: 10.1186/s13613-022-01022-8.

    PMID: 35633423BACKGROUND

Related Links

MeSH Terms

Conditions

Renal Insufficiency, ChronicCritical Illness

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

musa h UÇAR

CONTACT

+905456934995ucarharunmusa@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Anesthesiology and Reanimation

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 9, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

February 10, 2027

Study Completion (Estimated)

February 10, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share