Diuretic Effect and VExUS score in Cardio-Renal Syndrome - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Cardio-Renal Syndrome

Intervention / Treatment

Detailed Description

Cardiorenal syndrome encompasses a spectrum of disorders involving both the heart and kidneys in which acute or chronic dysfunction in 1 organ may induce acute or chronic dysfunction in the other organ.

Fluid overload is deleterious in critically ill patients; apart from increased mortality, it can cause end-organ damage, thereby increasing the incidence of acute kidney injury (AKI), length of stay in ICU, and duration of mechanical ventilation.

Elevation of central venous pressure is directly transmitted to the renal veins because venous vascular resistance is negligible. As the encapsulated kidney has little room to expand, venous congestion causes renal interstitial hydrostatic pressure to increase. Furthermore, as the post-glomerular vascular and tubular network is a low-pressure system , the increase in the renal interstitial pressure causes compression or even occlusion of renal tubules. That in turn results in reduction or even shut down of tubular flow and shut down in the glomerular filtration .

The venous excess ultrasound (VExUS) score incorporates hepatic venous, intrarenal venous Doppler, inferior vena cava (IVC) assessment, and portal vein Doppler. By utilizing multiple parameters, the negative aspects of individual parameters might get negated and could be considered as a reliable tool to assess congestion of kidneys.

The investigators hypothesise that VExUS score could be valuable in predicting cardiorenal patients who need ultrafiltration in ICU. In this study the investigators will use VEXSUS score to predict response to diuretic therapy, to evaluate patients' volume status, and to predict mortality in cardiorenal patient

Every patient will be subjected to

Medical history taking.
Complete physical examination.
Routine laboratory investigations including baseline urea, creatinine, electrolytes, urine analysis, complete blood count, coagulation profile, liver functions test, arterial blood gas, serum lactate and daily follow up urea, creatinine, and electrolytes.
ECG, echocardiography, and lung ultrasound.
Volume status will be assessed by urine output, CVP, mean arterial pressure.
The following work up.
- VExUS score (IVC assessment, hepatic venous, intrarenal venous Doppler and portal vein Doppler)
- Cardiorenal patient will receive diuretic therapy as a standard treatment in patients with VEXSUS score 1-3
- Daily VExUS score will be done
- Diuretic resistance will be defined as failure to produce 0.5 ml/kg/h of urine after administration of at least double the dose of the patient's home diuretic therapy or after administration of 250 mg of Lasix and 10 mg of Metolazone in diuretic naïve patient).

Study Type

Observational

Enrollment (Anticipated)

60

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

Name: Hany A. Habib, Master
Phone Number: 01010963829
Email: hanysaid1690@gmail.com

Study Contact Backup

Name: Ahmad B. Abdelrehim, MD
Phone Number: 01009820300
Email: ahmadbahie@yahoo.com

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cardiorenal patients above 18 years old

Description

Inclusion Criteria:

Patients with congestive heart failure and GFR less than 100 ml/minute

Exclusion Criteria:

Patients below 18 years old. Patients with liver cirrhosis and portal hypertension. Patients with IVC thrombus. Patients with inadequate ultrasonography window.

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

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response to diuretic Time Frame: Baseline	Response to diuretic therapy in cardiorenal patients (failure to produce 0.5 ml/kg/h of urine after administration of at least double the dose of the patient's home diuretic therapy or after administration of 250 mg of Lasix and 10 mg of Metolazone in diuretic naïve patientfailure to produce 0.5 ml/kg/h of urine after administration of at least double the dose of the patient's home diuretic therapy or after administration of 250 mg of Lasix and 10 mg of Metolazone in diuretic naïve patient)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU stay Time Frame: Through study completion, an average of 2 weeks	Length of ICU stay	Through study completion, an average of 2 weeks
Worsening renal function Time Frame: Through study completion, an average of 2 weeks	Measurement of Urea and Creatinine on admission and daily follow up Follow up the fluid chart daily (urine input and output) Calculation of eGFR using Cockcroft-Gault Formula on admission daily follow up	Through study completion, an average of 2 weeks
Need to ultrafiltration Time Frame: Baseline	Patient with symptoms and signs of pulmonary congestion with failure to respond to diuretic therapy and need for ultrafiltration session	Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

Study Director: Abdallah I. Kelany, MD, University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

April 13, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (Actual)

May 10, 2022

Study Record Updates

Last Update Posted (Actual)