NCT05938049

Brief Summary

  1. 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. 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.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 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

June 16, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

June 16, 2023

Last Update Submit

August 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

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

    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.

    percentage of participants with improved urine out put in ml/kg/h in groups A and B.

    at 48 hours

Secondary Outcomes (1)

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

    at 48 hours

Study Arms (2)

Group A

patients whom fluid management will be guided by their IVC \& carotid Doppler measurements

Device: IVC ultrasound & Carotid doppler

Group B

patients in whom the fluid management will not guided by IVC \& carotid Doppler measurements.

Interventions

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 A

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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))

You may qualify if:

  • Patients diagnosed with Acute Kidney Injury
  • age must be more than 18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Saxena A, Meshram SV. Predictors of Mortality in Acute Kidney Injury Patients Admitted to Medicine Intensive Care Unit in a Rural Tertiary Care Hospital. Indian J Crit Care Med. 2018 Apr;22(4):231-237. doi: 10.4103/ijccm.IJCCM_462_17.

    PMID: 29743761BACKGROUND
  • Miller TE, Bunke M, Nisbet P, Brudney CS. Fluid resuscitation practice patterns in intensive care units of the USA: a cross-sectional survey of critical care physicians. Perioper Med (Lond). 2016 Jun 16;5:15. doi: 10.1186/s13741-016-0035-2. eCollection 2016.

    PMID: 27313844BACKGROUND
  • Thanakitcharu P, Charoenwut M, Siriwiwatanakul N. Inferior vena cava diameter and collapsibility index: a practical non-invasive evaluation of intravascular fluid volume in critically-ill patients. J Med Assoc Thai. 2013 Mar;96 Suppl 3:S14-22.

    PMID: 23682518BACKGROUND
  • Levine AC, Shah SP, Umulisa I, Munyaneza RB, Dushimiyimana JM, Stegmann K, Musavuli J, Ngabitsinze P, Stulac S, Epino HM, Noble VE. Ultrasound assessment of severe dehydration in children with diarrhea and vomiting. Acad Emerg Med. 2010 Oct;17(10):1035-41. doi: 10.1111/j.1553-2712.2010.00830.x.

    PMID: 21040103BACKGROUND
  • Barbier C, Loubieres Y, Schmit C, Hayon J, Ricome JL, Jardin F, Vieillard-Baron A. Respiratory changes in inferior vena cava diameter are helpful in predicting fluid responsiveness in ventilated septic patients. Intensive Care Med. 2004 Sep;30(9):1740-6. doi: 10.1007/s00134-004-2259-8. Epub 2004 Mar 18.

    PMID: 15034650BACKGROUND
  • Blehar DJ, Glazier S, Gaspari RJ. Correlation of corrected flow time in the carotid artery with changes in intravascular volume status. J Crit Care. 2014 Aug;29(4):486-8. doi: 10.1016/j.jcrc.2014.03.025. Epub 2014 Apr 2.

    PMID: 24930363BACKGROUND
  • Hossein-Nejad H, Mohammadinejad P, Lessan-Pezeshki M, Davarani SS, Banaie M. Carotid artery corrected flow time measurement via bedside ultrasonography in monitoring volume status. J Crit Care. 2015 Dec;30(6):1199-203. doi: 10.1016/j.jcrc.2015.08.014. Epub 2015 Aug 22.

    PMID: 26410681BACKGROUND
  • Doctor M, Siadecki SD, Cooper D Jr, Rose G, Drake AB, Ku M, Suprun M, Saul T. Reliability, Laterality and the Effect of Respiration on the Measured Corrected Flow Time of the Carotid Arteries. J Emerg Med. 2017 Jul;53(1):91-97. doi: 10.1016/j.jemermed.2017.01.056. Epub 2017 Mar 25.

    PMID: 28351511BACKGROUND
  • Shokoohi H, Berry GW, Shahkolahi M, King J, King J, Salimian M, Poshtmashad A, Pourmand A. The diagnostic utility of sonographic carotid flow time in determining volume responsiveness. J Crit Care. 2017 Apr;38:231-235. doi: 10.1016/j.jcrc.2016.10.025. Epub 2016 Nov 9.

    PMID: 27987483BACKGROUND
  • Mackenzie DC, Khan NA, Blehar D, Glazier S, Chang Y, Stowell CP, Noble VE, Liteplo AS. Carotid Flow Time Changes With Volume Status in Acute Blood Loss. Ann Emerg Med. 2015 Sep;66(3):277-282.e1. doi: 10.1016/j.annemergmed.2015.04.014. Epub 2015 May 21.

    PMID: 26003002BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Ayman Mohamed, dectorate

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 16, 2023

First Posted

July 10, 2023

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 5, 2024

Record last verified: 2024-08