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Acute Kidney InjuryNCT06386796

Renal Resistive Index as a Predictor of Acute Renal Impairment in High-risk Patients

An observational study of Acute Kidney Injury and Critical Illness, run by Aswan University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To study the ability of RRI, measured by bedside Doppler ultrasound, in detecting acute kidney injury in high-risk patients admitted to surgical intensive care unit, Aswan university hospital, compared with renal biomarkers and conventional assessment using urine output and serum creatinine levels. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Kidney Injury, Critical Illness
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Apr 2024to 1 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients who are admitted to SICU, Aswan university hospital, after polytrauma, pre-eclampsia, eclampsia and sepsis

Who may be able to join

  • Patients with severe pre-eclampsia and eclampsia.
  • Polytraumatized patients.
  • Patients admitted to ICU with sepsis.
  • Both genders.
  • Patients above 18 years.

Who cannot join

  • patients known to have CKD.
  • patients with congenital renal anomalies.
  • patients with renal transplantation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Soudy S Hammad, MD contact

201014761523

soudi.salah@aswu.edu.eg

Tarek S Hemaida, MD contact

01007363190

dr.tarek@aswu.edu.eg

Egypt1 site, 1 recruiting

  • Aswan University

    Aswān, Aswan Governorate, 81528

    Soudy S Hammad, +201014761523, soudi.salah@aswu.edu.eg

    Tarek S Hemaida, 01007363190, dr.tarek@aswu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Renal Resistive Index as a Predictor of Acute Renal Impairment in High-risk Patients Admitted to Surgical Intensive Care Unit.

To study the ability of RRI, measured by bedside Doppler ultrasound, in detecting acute kidney injury in high-risk patients admitted to surgical intensive care unit, Aswan university hospital, compared with renal biomarkers and conventional assessment using urine output and serum creatinine levels.

Read the detailed description

Acute kidney injury (AKI) is a common clinical problem encountered in critically ill patients, frequently in the setting of multiple organ failure, and is an independent risk factor for increase hospital stay and mortality risk.

Early-stage acute kidney injury was first assessed based on the risk, injury, failure, loss and end-stage (RIFLE) criteria in 2004, and then by the Acute Kidney Injury Network (AKIN) criteria in 2007. The Kidney Disease: Improving Global Outcomes (KDIGO) classification, based on both the AKIN and RIFLE criteria, was introduced in 2012, offering an assessment based on baseline creatinine and urine output.

The best strategy in clinical practice is to identify AKI as early as possible, reverse its cause, and even improve the sequelae. In the past decades, several serum creatinine (SCr)-based classification systems have been proposed to define AKI.

The limitations of SCr is that the determinants of SCr (rate of production, apparent volume of distribution, and rate of elimination) are variable. Therefore, there is an unmet need for other objective measures to help detect AKI in a timely manner. The role of several biomarkers in the early prediction or risk assessment of AKI has been proposed, including kidney tubular damage markers (e.g., neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule-1 (KIM- 1), liver-type fatty acid-binding protein (L-FABP) and cystatin C).

Cystatin C is a protein from the family of cysteine proteinase inhibitors and is of interest as an early marker of decreased renal function. It is a protein that is synthesized at a constant rate by all cells containing nuclei, secreted into biological fluids: plasma, pleural, ascitic, cerebrospinal fluid, freely filtered through the glomerular membrane (due to its low molecular weight), fully metabolized in the kidneys, not secreted by the proximal renal tubules.

Renal resistive index (RRI) is a noninvasive instrument to evaluate kidney hemodynamics, and it is obtained by analysis of intrarenal arterial waves using Doppler ultrasound.

Keywords
renal resisitive index, surgical ICU, Cystatin C
Medical subject headings
Acute Kidney Injury, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early detection of acute kidney injury.

    Renal artery resistive index will be measured daily.Cystatin C will be measured on admission, after 24 hours and 72 hours.

    Measured: Day 0,1,2,3,7

  2. Diagnosis of acute kidney injury.

    Renal artery resistive index will be measured daily.Cystatin C will be measured on admission, after 24 hours and 72 hours.

    Measured: Day 0,1,2,3,7

Secondary outcomes (4)

  1. To grade the severity of AKI.

    Using the KDIGO criteria, AKI is staged as follows:

    Stage 1: Increase in serum creatinine to 1.5 to 1.9 times baseline, or increase in serum creatinine by ≥0.3 mg/dL, or reduction in urine output to <0.5 mL/kg/h for 6 to 12 h.

    Stage 2: Increase in serum creatinine to 2.0 to 2.9 times baseline, or reduction in urine output to <0.5 mL/kg/h for ≥12 h.

    Stage 3: Increase in serum creatinine to 3.0 times baseline, or increase in serum creatinine to ≥4.0 mg/dL, or reduction in urine output to <0.3 mL/kg/h for ≥24 h, or anuria for ≥12 h, or the initiation of renal replacement therapy, or, in patients <18 years, decrease in estimated glomerular filtration rate (eGFR) to <35 mL/min/1.73 m2.

    Measured: day 0,1,2,3,7

  2. To predict clinical outcome (clinical improvement)

    To predict clinical outcome (clinical improvement) at 30 days

    Measured: Day 0,1,2,3,7,30

  3. To predict clinical outcome (necessity for renal replacement therapy)

    To predict clinical outcome (necessity for renal replacement therapy) at 30 days

    Measured: Day 0,1,2,3,7,30

  4. To predict clinical outcome (death)

    To predict clinical outcome (death) at 30 days.

    Measured: Day 0,1,2,3,7,30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2024
  2. Study start1 Apr 2024
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06386796
Sponsor's protocol ID
Asw.U./867/11/23
Status last verified
Mar 2026
First submitted
4 Apr 2024
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pan HC, Yang SY, Chiou TT, Shiao CC, Wu CH, Huang CT, Wang TJ, Chen JY, Liao HW, Chen SY, Huang TM, Yang YF, Lin HY, Chan MJ, Sun CY, Chen YT, Chen YC, Wu VC. Comparative accuracy of biomarkers for the prediction of hospital-acquired acute kidney injury: a systematic review and meta-analysis. Crit Care. 2022 Nov 12;26(1):349. doi: 10.1186/s13054-022-04223-6.

    PubMed 36371256

  • Cruz EG, Broca Garcia BE, Sandoval DM, Gopar-Nieto R, Gonzalez Ruiz FJ, Gallardo LD, Ronco C, Madero M, Vasquez Jimenez E. Renal Resistive Index as a Predictor of Acute Kidney Injury and Mortality in COVID-19 Critically Ill Patients. Blood Purif. 2022;51(4):309-316. doi: 10.1159/000517469. Epub 2021 Jul 19.

    PubMed 34280921

  • Provenzano M, Rivoli L, Garofalo C, Faga T, Pelagi E, Perticone M, Serra R, Michael A, Comi N, Andreucci M. Renal resistive index in chronic kidney disease patients: Possible determinants and risk profile. PLoS One. 2020 Apr 1;15(4):e0230020. doi: 10.1371/journal.pone.0230020. eCollection 2020.

    PubMed 32236125

  • Fernando S, Polkinghorne KR. Cystatin C: not just a marker of kidney function. J Bras Nefrol. 2020 Mar;42(1):6-7. doi: 10.1590/2175-8239-JBN-2019-0240. Epub 2020 Apr 3. No abstract available.

    PubMed 32255469

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury and Critical Illness, run by Aswan University at 1 site in Egypt.

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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Soudy S Hammad, MD (201014761523, soudi.salah@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early detection of acute kidney injury. (time frame: Day 0,1,2,3,7). 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 NCT06386796, which also lists 4 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 10 Mar 2026.

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