The Predictive Performance of Renal Ultrasound on Changes... | NCT04198168

Studies
The Predictive Performance of Renal Ultrasound on Changes in Renal Clearance

NCT04198168

Sponsor

Aarhus University Hospital

Status

Terminated

Last Update Posted

Dec 9, 2020Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Acute Kidney Injury
Hypoperfusion
Fluid Overload

Interventions

IV crystalloid fluid bolus

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to the COVID-19 situation, it was not feasible to complete the study in our ICU.

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Nov 30, 2020Actual

Completion Date

Nov 30, 2020Actual

First Submitted Date

Nov 8, 2019

First Submission Date that Met QC Criteria

Dec 12, 2019

First Posted Date

Dec 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2020

Last Update Posted Date

Dec 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johan Fridolf Hermansen, Principal Investigator, Aarhus University HospitalPrincipal Investigator

Lead Sponsor

Aarhus University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Patients available for inclusion will receive a baseline administration of Tc-99-DTPA for precise determination of GFR/renal function by blood and urine samples.

Baseline values of ultrasound measures will be obtained, including renal arterial, renal venous, portal venous and hepatic venous Doppler measures and renal contrast enhanced ultrasound (CEUS) will also be recorded.

After two hours, baseline values of GFR are finished. The patient is then exposed to passive leg raising and ultrasound measures are repeated, including renal arterial, renal venous, portal venous and hepatic venous Doppler measures.

The participant then receives a standardised fluid bolus of 7 ml/kg (ideal body weight) Once the fluid bolus administration is complete, renal ultrasound is repeated, including renal arterial, renal venous, portal venous, hepatic venous Doppler measures and renal CEUS.

Follow-up determination of GFR/renal function based on Tc-99-DTPA after fluid therapy is repeated with blood and urine samples.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
IV crystalloid fluid bolus	Drug	The participant receives IV fluid as a standardised bolus of 7 ml/kg (ideal body weight).	ICU patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Renal venous flow classification	normal - abnormal (pulsatile/biphasic/monophasic	6 hours
Renal venous impedance index	(maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients admitted to the ICU at Aarhus University Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital, Department of Anaesthesiology		Aarhus		8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury
D004487	Edema
D006940	Hyperemia

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided