The Predictive Performance of Renal Ultrasound on Changes in Renal Clearance

NCT04198168 | Terminated

• 1 other identifier: 1-10-72-75-19
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The study will examine the ability of renal ultrasound (Doppler and Contrast Enhanced Ultrasound (CEUS)) in distinguishing ICU patients who exhibit increases in glomerular filtration rate (GFR) in response to fluid loading, from those for whom fluid loading is without benefit of directly harmful.

Conditions

Acute Kidney Injury; Hypoperfusion; Fluid Overload

Keywords

Ultrasound; Renal perfusion; Fluid treatment; Venous congestion; Renal function

Outcome Measures

Primary Outcomes (1)

• Changes in renal function in response to a standardised fluid bolus.

  Renal function is measures as Tc-99-Diethylenetriaminepentaacetic acid (DTPA) clearance.

  6 hours

Secondary Outcomes (12)

• Renal venous flow classification

  6 hours

• Renal venous impedance index

  6 hours

• Renal venous stasis index

  6 hours

• Renal arterial resistive index

  6 hours

• Portal venous pulsatility fraction

  6 hours

Study Arms (1)

ICU patients

ICU patients who are assessed by their attending physician as having need for fluid therapy and are planned to receive IV crystalloid fluid due to oliguria and/or to improve GFR.

Drug: IV crystalloid fluid bolus

Interventions

IV crystalloid fluid bolus DRUG

The participant receives IV fluid as a standardised bolus of 7 ml/kg (ideal body weight).

ICU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted to the ICU at Aarhus University Hospital

You may qualify if:

• Patients ≥ 18 years admitted to the ICU, Aarhus University Hospital.
• Patients who are assessed by their attending physician as having need for fluid therapy.

You may not qualify if:

• Insufficient ultrasound imaging of the kidneys.
• Pregnancy.
• Intolerance to any ultrasound contrast agent or isotopes, including intolerance for human albumin.
• Prior enrolment in a conflicting research study.
• Known morphological kidney disease.
• Need for dialysis.
• Need for extracorporeal membrane oxygenation (ECMO).
• Prior participation.
• Severe pulmonary hypertension (systolic pulmonary pressure \> 90 mmHg)

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital, Department of Anaesthesiology

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Acute Kidney Injury; Edema; Hyperemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular 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: November 8, 2019
• First Posted: December 13, 2019
• Study Start: January 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)