Clinical trial NCT06386796: Renal Resistive Index as a Predictor of Acute Renal Impairment in High-risk Patients
Official title: Renal Resistive Index as a Predictor of Acute Renal Impairment in High-risk Patients Admitted to Surgical Intensive Care Unit.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Critical Illness
Keywords: renal resisitive index
surgical ICU
Cystatin C
Lead sponsor: Aswan University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who are admitted to SICU, Aswan university hospital, after polytrauma, pre-eclampsia, eclampsia and sepsis

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.

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.

Primary outcomes:
measure: Early detection of acute kidney injury.
timeFrame: Day 0,1,2,3,7
measure: Diagnosis of acute kidney injury.
timeFrame: Day 0,1,2,3,7
Secondary outcomes:
measure: To grade the severity of AKI.
timeFrame: day 0,1,2,3,7
measure: To predict clinical outcome (clinical improvement)
timeFrame: Day 0,1,2,3,7,30
measure: To predict clinical outcome (necessity for renal replacement therapy)
timeFrame: Day 0,1,2,3,7,30
measure: To predict clinical outcome (death)
timeFrame: Day 0,1,2,3,7,30
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University
name: Mohamed H Abolwafa, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Sohag University
name: Ahmed E Abd Elrahman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.