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

NCT ID: NCT06386796

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-06-06

Brief 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.

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.

Conditions

Acute Kidney Injury; Critical Illness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aswan University

OTHER

Sponsor Role: lead

Responsible Party

Soudy Salah Hammad

Lecturer of anesthesia and surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed H Abolwafa, MSc

Role: PRINCIPAL_INVESTIGATOR

Aswan University

Ahmed E Abd Elrahman, MD

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

Aswan University

Aswān, Aswan Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Soudy S Hammad, MD

Role: CONTACT

soudi.salah@aswu.edu.eg

201014761523

Tarek S Hemaida, MD

Role: CONTACT

dr.tarek@aswu.edu.eg

01007363190

Facility Contacts

Soudy S Hammad

Role: primary

soudi.salah@aswu.edu.eg

+201014761523

Tarek S Hemaida

Role: backup

dr.tarek@aswu.edu.eg

01007363190

References

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.

Reference Type: BACKGROUND

PMID: 36371256 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34280921 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32236125 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32255469 (View on PubMed)

Other Identifiers

Asw.U./867/11/23

Identifier Type: -

Identifier Source: org_study_id