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NCT Number: NCT06386796

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

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.

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Key information

Conditions

Acute Kidney Injury Critical Illness Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Early detection of acute kidney injury.

    Time frame: Day 0,1,2,3,7

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

  2. Diagnosis of acute kidney injury.

    Time frame: Day 0,1,2,3,7

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

Secondary outcomes

  1. To grade the severity of AKI.

    Time frame: day 0,1,2,3,7

    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.

  2. To predict clinical outcome (clinical improvement)

    Time frame: Day 0,1,2,3,7,30

    To predict clinical outcome (clinical improvement) at 30 days

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

    Time frame: Day 0,1,2,3,7,30

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

  4. To predict clinical outcome (death)

    Time frame: Day 0,1,2,3,7,30

    To predict clinical outcome (death) at 30 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Soudy S Hammad, MD

CONTACT

[email protected]

201014761523

Tarek S Hemaida, MD

CONTACT

[email protected]

01007363190

Sponsors and collaborators

Lead sponsor

Aswan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2024
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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