Renal Resistive Index as a Predictor of Acute Kidney Injury and Evaluation of Fluid Administration in Sepsis

NCT ID: NCT06009445

Last Updated: 2023-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-07-01

Brief Summary

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We aim from this study to investigate the role of renal resistance index (RRI) in evaluation of Acute kidney injury development and fluid administration in sepsis patients considering the change in RRI values over 7 days from admission as a predictor of AKI development

Detailed Description

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Acute kidney injury (AKI) is one of the most common problems in critically ill patients in the clinic. AKI can be caused by various factors, such as hypovolemia, shock, major surgery, trauma, and heart failure, of which sepsis is the most common

Conditions

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Renal Resistive Index Acute Kidney Injury Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AKI group

Acute kidney injury (AKI) was defined according to the Kidney Disease Improving Global Outcome (KDIGO) classification using both creatinine and urine output criteria.

The KDIGO guidelines define AKI as follows:

* Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours, or
* Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days, or
* Urine volume \<0.5 mL/kg/hour for six hours

Renal resistive index

Intervention Type DIAGNOSTIC_TEST

The calculation formula for Renal resistive index (RRI) as follows :

(systolic peak flow velocity \_ diastolic minimum flow velocity )/systolic peak flow velocity .

will be measured with ultrasound-Doppler using an abdominal curvilinear probe ultrasonography by two independent, trained sonographers (who will not be involved in patient care. After visualizing the kidney in ultrasound mode and checking for renal abnormalities, an arcuate or interlobar artery will be localized and three successive doppler measurements at different positions in the kidney (high, middle and low) will be performed, 3 times in each kidney. So a total number of 9 RRI values will be obtained in each kidney.

The median value of each section will be used and the 3 median values of each kidney will be averaged.

Non AKI group

Patients who will no develop Acute kidney injury (AKI).

Renal resistive index

Intervention Type DIAGNOSTIC_TEST

The calculation formula for Renal resistive index (RRI) as follows :

(systolic peak flow velocity \_ diastolic minimum flow velocity )/systolic peak flow velocity .

will be measured with ultrasound-Doppler using an abdominal curvilinear probe ultrasonography by two independent, trained sonographers (who will not be involved in patient care. After visualizing the kidney in ultrasound mode and checking for renal abnormalities, an arcuate or interlobar artery will be localized and three successive doppler measurements at different positions in the kidney (high, middle and low) will be performed, 3 times in each kidney. So a total number of 9 RRI values will be obtained in each kidney.

The median value of each section will be used and the 3 median values of each kidney will be averaged.

Interventions

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Renal resistive index

The calculation formula for Renal resistive index (RRI) as follows :

(systolic peak flow velocity \_ diastolic minimum flow velocity )/systolic peak flow velocity .

will be measured with ultrasound-Doppler using an abdominal curvilinear probe ultrasonography by two independent, trained sonographers (who will not be involved in patient care. After visualizing the kidney in ultrasound mode and checking for renal abnormalities, an arcuate or interlobar artery will be localized and three successive doppler measurements at different positions in the kidney (high, middle and low) will be performed, 3 times in each kidney. So a total number of 9 RRI values will be obtained in each kidney.

The median value of each section will be used and the 3 median values of each kidney will be averaged.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Renal Doppler Ultrasound

Eligibility Criteria

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Inclusion Criteria

* Age over 21 years
* meet Sepsis 3 criteria (potential source of infection , host response and organ dysfunction) but not in septic shock.

Exclusion Criteria

* patients during pregnancy.
* patients with hepatorenal syndrome.
* Poor abdominal echogenicity eg.(morbid obesity ,increase intra abdominal pressure )
* Severe acute or chronic renal insufficiency .
* Dialysis dependency.
* Renal transplantation.
* Known renal artery stenosis.
* Mono-kidney, kidney tumor, anatomic kidney abnormalities.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Safinaz Abdelkhalek Aboelfetoh

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Safinaz A Aboelfetoh, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology, Faculty of Medicine, Tanta University, Egypt.

Locations

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Tanta University Hospitals

Tanta, Elgharbia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Safinaz A Aboelfetoh, MBBCh

Role: CONTACT

00201148855752

Facility Contacts

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Safinaz A Aboelfetoh, MBBCh

Role: primary

00201148855752

Other Identifiers

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36264MS189/5/23

Identifier Type: -

Identifier Source: org_study_id

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