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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05938049
Collaborator
(none)
60
16

Study Details

Study Description

Brief Summary

  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.

Condition or Disease Intervention/Treatment Phase
  • Device: IVC ultrasound & Carotid doppler

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Carotid Doppler and Inferior Vena Cava Measuerments for Volume Guided Management in Acute Kidney Injury Patients
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. percentage of participants with improved serum creatinine level in µmol/L in groups A and B. [at 48 hours]

    percentage of participants with improved serum creatinine level in µmol/L in groups A and B.

  2. percentage of participants with improved urine out put in ml/kg/h 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.

Secondary Outcome Measures

  1. percentage of participants with improved mean arterial blood pressure in mmHg in groups A and B. [at 48 hours]

    percentage of participants with improved mean arterial blood pressure in mmHg in groups A and B.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ayman Abdallah Mahmoud, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05938049
Other Study ID Numbers:
  • CD&IVC in AKI
First Posted:
Jul 10, 2023
Last Update Posted:
Jul 11, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2023