Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04198168
Other study ID # 1-10-72-75-19
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date November 30, 2020

Study information

Verified date December 2020
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date November 30, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark Aarhus University Hospital, Department of Anaesthesiology Aarhus

Sponsors (1)

Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Renal venous flow classification normal - abnormal (pulsatile/biphasic/monophasic 6 hours
Secondary Renal venous impedance index (maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity 6 hours
Secondary Renal venous stasis index (index cardiac cycle time - venous flow time) / index cardiac cycle time 6 hours
Secondary Renal arterial resistive index (maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity 6 hours
Secondary Portal venous pulsatility fraction (maximum flow velocity - minimum diastolic flow velocity) / maximum flow velocity 6 hours
Secondary Contrast enhanced ultrasound 1 Mean transit time (mTT) 6 hours
Secondary Contrast enhanced ultrasound 2 Perfusion Index (PI) 6 hours
Secondary Contrast enhanced ultrasound 3 Relative Blood Volume (rBV) 6 hours
Secondary Contrast enhanced ultrasound 4 Wash-in Rate (WiR) 6 hours
Secondary Contrast enhanced ultrasound 5 Quality Of Fit (QOF) 6 hours
Secondary Continuous recordings of hemodynamic variables 1 arterial pressure 6 hours
Secondary Continuous recordings of hemodynamic variables 2 Central venous pressure 6 hours
See also
  Status Clinical Trial Phase
Recruiting NCT05538351 - A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Completed NCT03938038 - Guidance of Ultrasound in Intensive Care to Direct Euvolemia N/A
Recruiting NCT05805709 - A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial N/A
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Recruiting NCT05897840 - Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients N/A
Recruiting NCT04986137 - Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
Terminated NCT04293744 - Acute Kidney Injury After Cardiac Surgery N/A
Completed NCT04095143 - Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
Not yet recruiting NCT06026592 - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Not yet recruiting NCT06064305 - Transcriptional and Proteomic Analysis of Acute Kidney Injury
Terminated NCT03438877 - Intensive Versus Regular Dosage For PD In AKI. N/A
Terminated NCT03305549 - Recovery After Dialysis-Requiring Acute Kidney Injury N/A
Completed NCT05990660 - Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery N/A
Completed NCT04062994 - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Terminated NCT02860130 - Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT) Phase 3
Completed NCT06000098 - Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
Not yet recruiting NCT05548725 - Relation Between Acute Kidney Injury and Mineral Bone Disease
Completed NCT02665377 - Prevention of Akute Kidney Injury, Hearttransplant, ANP Phase 3
Terminated NCT03539861 - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients N/A