Acute Kidney InjuryNCT05938049
Carotid Doppler and IVC Measurements for Volume Guided Management in Acute Kidney Injury Patients
An observational study of Acute Kidney Injury, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- IVC ultrasound & Carotid doppler
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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))
Who may be able to join
- Patients diagnosed with Acute Kidney Injury
- age must be more than 18 years
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Carotid Doppler and Inferior Vena Cava Measuerments for Volume Guided Management in Acute Kidney Injury Patients
- 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.
- 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.
Read the 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 .
- Conditions
- Acute Kidney Injury
- Being tested
- IVC ultrasound & Carotid doppler
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVC ultrasound & Carotid dopplerDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | patients whom fluid management will be guided by their IVC \& carotid Doppler measurements Receives: Device: IVC ultrasound & Carotid doppler | |
| Group B | patients in whom the fluid management will not guided by IVC \& carotid Doppler measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at 48 hours
Secondary outcomes (1)
percentage of participants with improved mean arterial blood pressure in mmHg in groups A and B.
percentage of participants with improved mean arterial blood pressure in mmHg in groups A and B.
Measured: at 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Abdallah Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938049
- Sponsor's protocol ID
- CD&IVC in AKI
- Status last verified
- Aug 2024
- First submitted
- 16 Jun 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29743761Miller 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.
PubMed 27313844Thanakitcharu 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.
PubMed 23682518Levine 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.
PubMed 21040103Barbier 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.
PubMed 15034650Blehar 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.
PubMed 24930363Hossein-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.
PubMed 26410681Doctor 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.
PubMed 28351511Shokoohi 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.
PubMed 27987483Mackenzie 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.
PubMed 26003002
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Doppler and Inferior Vena Cava Measuerments for Volume Guided Management in Acute Kidney Injury Patients
- ClinicalTrials.gov ID
- NCT05938049
- Acronym / sponsor ID
- CD&IVC in AKI
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: IVC ultrasound & Carotid dopplerpatients whom fluid management will be guided by their IVC \& carotid Doppler measurements |
| Group B | – | –patients in whom the fluid management will not guided by IVC \& carotid Doppler measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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))
Key inclusion criteria (2 listed)
- Patients diagnosed with Acute Kidney Injury
- age must be more than 18 years
Key exclusion criteria (6 listed)
- Morbid obesity (BMI >35)
- End Stage Renal Disease (ESRD) on dialysis
- Sever ventricular dysfunction, valvular heart disease
- Carotid stenosis >50%
- chronic obstructive pulmonary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVC ultrasound & Carotid dopplerbed 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 | Device | Group A |
Primary outcome
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.
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.
1 secondary outcome
percentage of participants with improved mean arterial blood pressure in mmHg in groups A and B.
Time frame: at 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 29743761Saxena 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.
- Background: PubMed 27313844Miller 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.
- Background: PubMed 23682518Thanakitcharu 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.
- Background: PubMed 21040103Levine 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.
- Background: PubMed 15034650Barbier 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.
- Background: PubMed 24930363Blehar 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.
- Background: PubMed 26410681Hossein-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.
- Background: PubMed 28351511Doctor 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.
- Background: PubMed 27987483Shokoohi 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.
- Background: PubMed 26003002Mackenzie 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayman Mohamed, dectorate (+201032413647, nephrologyman90@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of participants with improved serum creatinine level in µmol/L in groups A and B. (time frame: at 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05938049, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.