NCT06386796

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Apr 2024

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 Progress84%
Apr 2024Oct 2026

Study Start

First participant enrolled

April 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

April 4, 2024

Last Update Submit

March 6, 2026

Conditions

Keywords

renal resisitive indexsurgical ICUCystatin C

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • To grade the severity of AKI.

    day 0,1,2,3,7

  • To predict clinical outcome (clinical improvement)

    Day 0,1,2,3,7,30

  • To predict clinical outcome (necessity for renal replacement therapy)

    Day 0,1,2,3,7,30

  • To predict clinical outcome (death)

    Day 0,1,2,3,7,30

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients with severe pre-eclampsia and eclampsia.
  • Polytraumatized patients.
  • Patients admitted to ICU with sepsis.
  • Both genders.
  • Patients above 18 years.

You may not qualify if:

  • patients known to have CKD.
  • patients with congenital renal anomalies.
  • patients with renal transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University

Aswān, Aswan Governorate, 81528, Egypt

RECRUITING

Related Publications (4)

  • 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: 36371256BACKGROUND
  • 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: 34280921BACKGROUND
  • 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: 32236125BACKGROUND
  • 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: 32255469BACKGROUND

MeSH Terms

Conditions

Acute Kidney InjuryCritical Illness

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed H Abolwafa, MSc

    Aswan University

    PRINCIPAL INVESTIGATOR
  • Ahmed E Abd Elrahman, MD

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Soudy S Hammad, MD

CONTACT

Tarek S Hemaida, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and surgical intensive care

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 26, 2024

Study Start

April 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations