NCT06174610

Brief Summary

The aim of the study is to determine whether there is a correlation between changes in the renal resistive index and the restoration of kidney function in critically ill patients undergoing continuous renal replacement therapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Dec 2023Dec 2026

First Submitted

Initial submission to the registry

December 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

December 19, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2026

Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

2.4 years

First QC Date

December 1, 2023

Last Update Submit

May 28, 2025

Conditions

Keywords

Acute Kidney Injury (AKI)Continous Renal Replacement Therapy (CRRT)Critical CareRenal Resistive Index (RRI)

Outcome Measures

Primary Outcomes (1)

  • Relationship between changes in RRI and recovery of kidney function

    The first ultrasound examination should be performed before the initiation of CRRT and, if not possible, within 24 hours of starting CRRT. Subsequently, the renal arteries will be assessed once a day during CRRT and after its completion until kidney function improves or there is a need for a return to renal replacement therapy. The return of kidney function is defined as a stable (increase \<0.3 mg/dl/24h) or decreasing serum creatinine level in two consecutive tests conducted at intervals of at least 24 hours and an average hourly diuresis \>0.5 ml/kg over the last 12 hours, with or without loop diuretics.

    on average from 1 to 3 weeks

Study Arms (1)

Acute Kidney Injury + CRRT

Critically ill patients admitted to the intensive care unit (ICU), undergoing continuous renal replacement therapy due to Acute Kidney Injury. Diagnostic Test: Daily Doppler measurement of Renal Resistive Index

Diagnostic Test: Measurement of Renal Resistive Index

Interventions

The kidneys are preliminarily visualized in a 2D projection, followed by identifying interlobar or arcuate vessels using color Doppler. Flow measurements in these vessels are performed using pulsed-wave Doppler. Renal Resistive Index is determined over three cardiac cycles (five in the case of atrial fibrillation) in two different arteries, each in a different kidney section. Subsequently, measurements from each artery are averaged. If possible, the examination should be conducted bilaterally. The investigators do not have access to previous measurements (each study is recorded on a separate card).

Acute Kidney Injury + CRRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult ICU patients undergoing CRRT due to AKI

You may qualify if:

  • All ICU patients undergoing CRRT due to AKI

You may not qualify if:

  • age \<18 years
  • pregnancy
  • history of chronic kidney disease in stage 4 or 5
  • post-kidney transplant status
  • mechanical circulatory support
  • occurrence of one or more conditions preventing reliable RRI measurement in both kidneys:
  • challenging technical conditions of ultrasound examination, hindering proper visualization of the kidney
  • post-kidney injury in grade III and higher, according to AAST
  • advanced parenchymal kidney pathology: atrophy, hypoplasia, cirrhosis, extensive ischemia (more than 2/3 of the parenchyma),
  • kidney diseases preventing parenchyma identification: advanced cancer (stage above T1 according to TNM), certain forms of polycystic kidney disease
  • inflammatory kidney diseases
  • obstructive uropathy
  • renal vascular pathologies: renal vein thrombosis, significant stenosis (\>60%), and renal artery occlusion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Opole, Opole Voivodeship, 45-372, Poland

RECRUITING

Related Publications (5)

  • Patriquin HB, O'Regan S, Robitaille P, Paltiel H. Hemolytic-uremic syndrome: intrarenal arterial Doppler patterns as a useful guide to therapy. Radiology. 1989 Sep;172(3):625-8. doi: 10.1148/radiology.172.3.2672090.

    PMID: 2672090BACKGROUND
  • Katulka RJ, Al Saadon A, Sebastianski M, Featherstone R, Vandermeer B, Silver SA, Gibney RTN, Bagshaw SM, Rewa OG. Determining the optimal time for liberation from renal replacement therapy in critically ill patients: a systematic review and meta-analysis (DOnE RRT). Crit Care. 2020 Feb 13;24(1):50. doi: 10.1186/s13054-020-2751-8.

    PMID: 32054522BACKGROUND
  • Fernandez SN, Santiago MJ, Gonzalez R, Lopez J, Solana MJ, Urbano J, Lopez-Herce J. Changes in hemodynamics, renal blood flow and urine output during continuous renal replacement therapies. Sci Rep. 2020 Nov 27;10(1):20797. doi: 10.1038/s41598-020-77435-x.

    PMID: 33247145BACKGROUND
  • Fernandez SN, Lopez J, Gonzalez R, Solana MJ, Urbano J, Aguado A, Lancharro A, Lopez-Herce J, Santiago MJ. Doppler ultrasound in the assessment of renal perfusion before and during continuous kidney replacement therapy in the pediatric intensive care unit. Pediatr Nephrol. 2022 Dec;37(12):3205-3213. doi: 10.1007/s00467-022-05428-1. Epub 2022 Mar 14.

    PMID: 35286455BACKGROUND
  • Ninet S, Schnell D, Dewitte A, Zeni F, Meziani F, Darmon M. Doppler-based renal resistive index for prediction of renal dysfunction reversibility: A systematic review and meta-analysis. J Crit Care. 2015 Jun;30(3):629-35. doi: 10.1016/j.jcrc.2015.02.008. Epub 2015 Feb 24.

    PMID: 25746587BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 18, 2023

Study Start

December 19, 2023

Primary Completion (Estimated)

May 21, 2026

Study Completion (Estimated)

December 18, 2026

Last Updated

June 3, 2025

Record last verified: 2025-05

Locations