Renal Resistive Index in Patients With Shock

May 9, 2016 updated by: H.M. Oudemans-van Straaten, MD, PhD, Amsterdam UMC, location VUmc

Relation Between the Renal Resistive Index and Markers of the Systemic Circulation, the Microcirculation, Fluid Status and of Renal Function.

This study consists of two substudies.

The first substudy:

'Renal resistive index in critically ill patients with cardiogenic and septic shock'

Design: cross-sectional observational

Aim of this project is:

  1. to determine whether critically ill patients with cardiogenic and septic shock have an elevated Renal Resistive Index and
  2. to determine whether Renal Resistive Index differs between cardiogenic/hypovolemic shock and shock due to sepsis/systemic inflammation (SIRS)

  3. to determine the relation between the (change in) renal vascular resistance and

    • Markers of the systemic - and the microcirculation
    • Fluid status as quantified by bioimpedance analysis
    • Concomitant renal function

The second substudy:

'Predictive value of the Renal Resistive Index on ICU admission and its course for the development of acute kidney injury in critically ill patients with cardiogenic and septic shock'

Design: longitudinal observational

The aim of this project is:

  1. to determine whether the renal resistance index on admission to the intensive care unit can predict the development of acute kidney injury (AKI) in critically ill patients with shock
  2. to investigate if the renal resistance index on admission to the intensive care unit is an independent predictor of the development of AKI or depends on the severity and duration of shock and other known risk factors of AKI such as comorbidity and use of nephrotoxic drugs

Aim of the large research project is to determine whether the Renal Resistive Index could become a monitoring tool for intervention studies aiming to prevent acute kidney injury or protect the kidney.

Study Overview

Status

Completed

Conditions

Detailed Description

Acute Kidney Injury (AKI) is a severe complication developing in intensive care patients as a result of hypovolemic, cardiogenic or septic shock. It is defined by an abrupt decrease in kidney function. It encompasses both direct injury to the kidney as well as acute impairment of function, including decreased glomerular filtration rate (GFR). Its prevention is crucial because AKI increases morbidity and mortality (1). Mechanisms comprise ischemia/reperfusion, oxidative stress, inflammation and toxicity (2).The common pathophysiological pathway includes endothelial damage to microvessels leading to impaired macro- and microvascular flow and this will aggravate ischemia (3).

Up to now, much controversy exists about

  • the changes in renal blood flow during different kinds of shock
  • the relation between renal blood flow, glomerular filtration rate and the development of AKI
  • the relation between renal blood flow and markers of the systemic and microcirculation

In this prospective observational study, three study measurement will be performed in two groups of critically ill patients (shock and no shock).

  1. The Renal Resistive Index (RRI) will be determined using Renal Doppler Ultrasound . The renal resistive index (RRI) is a sonographic index assessing resistance of the intrarenal arcuate or interlobar arteries and is used to assess renal arterial disease. It is measured as RRI = (peak systolic velocity - end diastolic velocity)/peak systolic velocity. The normal value is ≈ 0,60, with 0,70 being around the upper limits of normal.
  2. The sublingual microcirculation will be quantified using side stream dark field imaging (SDF)
  3. Fluid status will be determined by Bioelectrical impedance analysis (BIA) using the Akern device.

In addition, routinely measured markers of circulation, renal function and fluid balance will be collected for analysis.

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • VU Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients, admitted tot the Intensive Care Unit (ICU)

Variables will be measured in a population of 80 adult patients admitted tot the Intensive Care Unit. This group consists of two groups of 40 patients. The first group consists of 40 patients with cardiogenic or septic shock, the second group will be the control group being intensive care patients without shock. The patients with shock are at increased risk for developing Acute Kidney Injury (AKI).

Description

Inclusion Criteria:

First group (patients with shock):

  • Critically ill patients admitted to the intensive care unit (ICU) with cardiogenic shock or shock due to sepsis/SIRS or hemorrhage
  • Age > 18 years
  • Noradrenalin support
  • ICU admission < 24 hours
  • Signed informed consent

Second group (patients without shock):

  • Critically ill patients admitted to the intensive care unit (ICU) without shock, without vasopressor support and without fluid-dependent circulation
  • Age > 18 years
  • ICU admission < 24-h
  • Signed informed consent

In both groups, written consent will be obtained if and when the patients are awake and able to communicate ('deferred consent')

Exclusion Criteria:

  • Severe pre-admission chronic renal insufficiency (eGFR < 30 ml/min)
  • Dialysis dependency
  • Renal transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with shock

Critically ill patients admitted to the intensive care unit (ICU)

  • with shock due sepsis/SIRS, cardiac failure or hemorrhage
  • age > 18 years,
  • noradrenalin support
  • < 24 hours of ICU admission
  • Signed informed consent
Patients without shock

Critically ill patients admitted to the intensive care unit (ICU)

  • without shock, without vasopressor support and without fluid dependent circulation
  • age > 18 years
  • < 24 hours of ICU admission
  • Signed informed consent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
renal resistive index (RRI)
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Creatine clearance (marker of GFR)
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Investigators

  • Study Director: Heleen M. Oudemans, Prof. Dr., Amsterdam Umc, Location Vumc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC-2015.025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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