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Recruiting NCT06386796

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

Observational Acute Kidney Injury Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Kidney Injury, Critical Illness. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Early detection of acute kidney injury. [Time frame: Day 0,1,2,3,7]
  • Diagnosis of acute kidney injury. [Time frame: Day 0,1,2,3,7]
Secondary outcome measures (4)
  • To grade the severity of AKI. [Time frame: day 0,1,2,3,7]
  • To predict clinical outcome (clinical improvement) [Time frame: Day 0,1,2,3,7,30]
  • To predict clinical outcome (necessity for renal replacement therapy) [Time frame: Day 0,1,2,3,7,30]
  • To predict clinical outcome (death) [Time frame: Day 0,1,2,3,7,30]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Aswan University — Aswān

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. PMID 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. PMID 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. PMID 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. PMID 32255469

Identifiers

NCT: NCT06386796 · Asw.U./867/11/23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗