Carotid Doppler and IVC Measurements for Volume Guided Management in Acute Kidney Injury Patients

August 2, 2024 updated by: Ayman Abdallah Mahmoud, Assiut University

Carotid Doppler and Inferior Vena Cava Measuerments for Volume Guided Management in Acute Kidney Injury Patients

  1. Evaluate Inferior Vena Cava Indices (Diameters , IVC-CI)&carotid doppler measurements (corrected Carotid Flow Time ,Carotid Blood Flow ,Carotid Artery Peak Velocity Variations) as Non-Invasive Technique for volume guided management in AKI Patient.
  2. Estimate correlation between IVC (Diameters , IVC-CI) & carotid doppler measurements (corrected Carotid Flow Time ,Carotid Blood Flow ,Carotid Artery Peak Velocity Variations) as Non-Invasive Technique for volume guided management in AKI Patient.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Acute kidney injury affects increasing numbers of patients worldwide, it was estimated approximately 15% of all subjects treated in hospitals develop Acute kidney injury,even a small increase in serum creatinine may be associated with increased risk of mortality , Oliguric AKI it imposes a great challenge for fluid management.

Recently, ultrasonography for estimating volume status has been widely recommended because of its non-invasive nature, ease of acquisition, and reproducibility of measurements.Among these ultrasound modalities, ultrasonographic assessment of the inferior vena cava & Carotid doppler measurements .

In spontaneously breathing patients, the inferior vena cava (IVC) diameter and the IVC Collapsibility Index (IVC-CI) have been shown to correlate with the volume status and central venous pressure (CVP) . also has been shown to indicate fluid status in children , ventilated patients and healthy volunteers .

corrected Carotid Flow Time (CFT) unaffected by respiration predicting fluid responsiveness that has shown promising results.Studies to date have shown that corrected CFT increases in response to fluid administration or consumption , and decreases in response to volume removal in dialysis and blood donation .

Study Type

Observational

Enrollment (Estimated)

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

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

N/A

Sampling Method

Non-Probability Sample

Study Population

consecutive Patients admitted to hospital with AKI or developing AKI during hospital admission course (AKI can be defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines either an elevation in serum creatinine (≥ 26.5 µmol/L or ≥1.5 folds of base line) or a reduced urine output (<0.5 ml/kg/h for 6 hours or more))

Description

Inclusion Criteria:

  1. Patients diagnosed with Acute Kidney Injury
  2. age must be more than 18 years

Exclusion Criteria:

  1. Morbid obesity (BMI >35)
  2. End Stage Renal Disease (ESRD) on dialysis
  3. Sever ventricular dysfunction, valvular heart disease
  4. Carotid stenosis >50%
  5. chronic obstructive pulmonary disease.
  6. Pregnancy & tense ascites

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
patients whom fluid management will be guided by their IVC & carotid Doppler measurements
Device: IVC ultrasound & Carotid doppler

bed side ultrasonographic assessement of inferior vena cava maximum and minimum diameters 2 to 5 cm caudal to its junction with the right atrium over a single respiratory cycle , inferior vena cava collapsibility index (IVC-CI) will calculated as (IVC max - IVC min)/IVC max).

carotid doppler assessment (2-3 cm proximal to the carotid bulb in the longitudinal plane) of corrected carotid flow time(systole time/√cycle time) ,carotid artery peak velocity variation calculated as ([PV max- PV min]/PV mean) × 100, where PV mean = (PV max + PV min)/2. during three consecutive respiratory cycles. as part of their routine care and assessment
Group B
patients in whom the fluid management will not guided by IVC & carotid Doppler measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of participants with improved serum creatinine level in µmol/L in groups A and B.
Time Frame: at 48 hours
percentage of participants with improved serum creatinine level in µmol/L in groups A and B.
at 48 hours
percentage of participants with improved urine out put in ml/kg/h in groups A and B.
Time Frame: at 48 hours
percentage of participants with improved urine out put in ml/kg/h in groups A and B.
at 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of participants with improved mean arterial blood pressure in mmHg in groups A and B.
Time Frame: at 48 hours
percentage of participants with improved mean arterial blood pressure in mmHg in groups A and B.
at 48 hours

Collaborators and Investigators

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

Sponsor

Assiut 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 (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Estimated)

August 5, 2024

Last Update Submitted That Met QC Criteria

August 2, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD&IVC in AKI

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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