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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Acute Kidney Injury

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Soudy S Hammad, MD; Phone Number: 201014761523; Email: soudi.salah@aswu.edu.eg
• Study Contact Backup: Name: Tarek S Hemaida, MD; Phone Number: 01007363190; Email: dr.tarek@aswu.edu.eg

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Recruiting
    • Aswan University
    • Contact: soudy S hammad; Phone Number: +201014761523; Email: soudi.salah@aswu.edu.eg
    • Contact: tarek S hemaida; Phone Number: 01007363190; Email: dr.tarek@aswu.edu.eg
    • Principal Investigator: mohamed H Abolwafa, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0,1,2,3,7
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.	Day 0,1,2,3,7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 0,1,2,3,7
To predict clinical outcome (clinical improvement)	To predict clinical outcome (clinical improvement) at 30 days	Day 0,1,2,3,7,30
To predict clinical outcome (necessity for renal replacement therapy)	To predict clinical outcome (necessity for renal replacement therapy) at 30 days	Day 0,1,2,3,7,30
To predict clinical outcome (death)	To predict clinical outcome (death) at 30 days.	Day 0,1,2,3,7,30

Collaborators and Investigators

• Sponsor: Aswan University
• Investigators: Principal Investigator: Mohamed H Abolwafa, MSc, Aswan University; Principal Investigator: Ahmed E Abd Elrahman, MD, Sohag University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): June 6, 2025

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Estimated): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Cystatin C; surgical ICU; renal resisitive index
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Critical Illness; Acute Kidney Injury
• Other Study ID Numbers: Asw.U./867/11/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No