NCT06389708

Brief Summary

Heart failure is a syndrome that progresses with symptoms and signs caused by cardiac dysfunction and results in a shortened life expectancy (1). Acute heart failure resulting in hospitalization is a significant cause of morbidity and mortality. With the increase in the severity of the disease and rapid advances in the treatment of heart failure, these patients are frequently hospitalized and monitored in intensive care. (2) Five years after diagnosis, mortality can be up to 67%. Additionally, it is known that patients with heart failure are hospitalized on average once a year after diagnosis. (3) In a multicenter study, it constituted 14% of 3000 cardiac patients admitted to intensive care units. Additionally, due to longer ICU stays, these patients accounted for 33% of total inpatient days. An increasing number of heart failure patients require intensive care due to respiratory failure, regardless of left ventricular ejection fraction. Heart failure accounts for approximately one-third of patient days in intensive care units, and this burden is increasing. This shows that attention should be paid to the quality of care for patients requiring critical care. (2) Multidisciplinary programs have been implemented to deal with the high prevalence. However, the optimal follow-up frequency is unknown. Therefore, some tools are needed to improve patient prognosis (3). Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker whose values in both urine and plasma have been associated with acute kidney injury (AKI). Although NGAL is an early specific biomarker for AKI, it has not yet come into routine use, but is frequently used in clinical and experimental studies (4). Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

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

First Submitted

Initial submission to the registry

April 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

April 25, 2024

Last Update Submit

April 30, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • VEXUS

    Venous excess ultrasound score

    at the first day, at the last day

  • MORTALİTY

    28 day mortality

    in 28 days

  • AKI

    Acute kidney injury rate

    last day

Study Arms (1)

Group 1

heart failure patients

Eligibility Criteria

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

heart failure patients in the ICU

You may qualify if:

  • Patients with a life expectancy of more than 24 hours
  • \>18 age

You may not qualify if:

  • Poor abdominal echogenicity
  • age \< 18
  • postoperative patients,
  • intoxications,
  • life expectancy is less than 24 hours,
  • pregnancy,
  • intraperitoneal pressure \> 15 mm Hg,
  • obstructive renal failure or suspected,
  • presence of renal artery stenosis,
  • patients who have had liver and kidney transplants,
  • Presence of liver and kidney tumors,
  • patients receiving dialysis treatment,
  • single kidney and other kidney abnormalities,
  • presence of acute mesenteric ischemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart FailureAcute Kidney Injury

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Intensive Care Unit

Study Record Dates

First Submitted

April 25, 2024

First Posted

April 29, 2024

Study Start

May 15, 2024

Primary Completion

December 15, 2024

Study Completion

January 15, 2025

Last Updated

May 1, 2024

Record last verified: 2024-04