Effects of Vena Cava Inferior Measurements on AKI and Mortality.

April 22, 2024 updated by: Ayse Belin Ozer, Inonu University

Determination of the Effects of Vena Cava Inferior Measurements on Acute Kidney Injury and Mortality During Intensive Care Admission.

Fluid overload is harmful in critically ill patients; In addition to increasing mortality, it may increase the incidence of acute kidney injury (AKI), length of ICU stay, and duration of mechanical ventilation by causing end-organ damage. (1-3) Mortality attributable to AKI is 20% and is an independent determinant of mortality. (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. When the IVC diameter is < 2 cm, it means there is no congestion and VEXUS is 0. Mild congestion: In addition to the IVC measuring approximately 2 cm, normal patterns such as the systolic wave being greater than the diastolic wave in the hepatic vein PW-doppler, pulsatility below 30% in the portal vein Doppler, continuous flow in the renal vein PW-doppler, or slightly abnormal patterns, i.e. hepatic The systolic wave in vein PW-doppler is smaller than the diastolic wave, the pulsatility in portal PW-doppler is between 30-50%, and the renal vein PW-doppler is accompanied by biphasic flow, and VEXUS is scored as 1. Moderate congestion is scored as VEXUS 2, which is measured as IVC 2 cm or more, plus inversion of the systolic wave on hepatic vein PW-doppler, pulsatility greater than 50% on portal PW-doppler, and discontinuous monophasic flow with only the diastolic phase on renal vein PW-doppler. It is accompanied by one of the serious abnormal patterns such as There is severe congestion, that is, VEXUS 3: IVC diameter of 2 cm or more and the presence of at least two seriously abnormal PW-Doppler morphologies. (5) The primary aim of this study is to describe the prevalence of venous congestion based on VExUS in general ICU patients. Secondary outcomes were to evaluate the association between VExUS, AKI, and 28-day mortality.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

In the first 24 hours of hospitalization, the inferior vena cava will be evaluated by an experienced clinician (INTENSIVE CARE SPECIALIST). If the IVC diameter is below 2 cm, the collapsibility index will be checked if the patient is not receiving mechanical ventilation (MV) treatment, and the distensibility index will be checked if the patient is receiving MV treatment. If the IVC diameter is over 2 cm, VEXUS will be performed. As primary outcomes, the development of acute kidney injury within one week and 28-day mortality will be recorded. Acute kidney injury will be performed according to KDIGO criteria. Patients' age, gender, body mass index, comorbidities, medications used before admission to intensive care (especially ACE inhibitors and ARBs), reason for admission to intensive care, fluid therapy applied in the first 24 hours, and fluid balance in the first 24 hours will be recorded. In patients taken from the emergency department, the amount of fluid taken and removed in the emergency room will also be recorded. Additionally, the use of vasopressors/vasodilators, inotropes, diuretics, colloids and blood products will be recorded. The central venous pressure of patients with a central venous catheter will also be recorded on the first day.

Patients will undergo transthoracic echocardiography and lung ultrasonography simultaneously, and ejection fraction and TAPSE will be evaluated.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to intensive care

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute kidney injury
Time Frame: 7 days
7 days
mortality
Time Frame: 28 days
in 28 days mortality
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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