Renal Resistive Index in Patients With Shock

NCT02558166 | Completed

• 1 other identifier: METC-2015.025
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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:
• 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
• 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

Conditions

Hypovolemic Shock; Cardiogenic Shock; Septic Shock; Kidney Failure, Acute

Keywords

Acute Kidney Injury (AKI); Renal Resistive Index (RRI)

Outcome Measures

Primary Outcomes (1)

• renal resistive index (RRI)

  1 week

Secondary Outcomes (1)

• Creatine clearance (marker of GFR)

  1 week

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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')

You may not qualify if:

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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Related Publications (8)

• Hoste EA, Schurgers M. Epidemiology of acute kidney injury: how big is the problem? Crit Care Med. 2008 Apr;36(4 Suppl):S146-51. doi: 10.1097/CCM.0b013e318168c590.

  PMID: 18382186 BACKGROUND

• Basile DP, Anderson MD, Sutton TA. Pathophysiology of acute kidney injury. Compr Physiol. 2012 Apr;2(2):1303-53. doi: 10.1002/cphy.c110041.

  PMID: 23798302 BACKGROUND

• Gomez H, Ince C, De Backer D, Pickkers P, Payen D, Hotchkiss J, Kellum JA. A unified theory of sepsis-induced acute kidney injury: inflammation, microcirculatory dysfunction, bioenergetics, and the tubular cell adaptation to injury. Shock. 2014 Jan;41(1):3-11. doi: 10.1097/SHK.0000000000000052.

  PMID: 24346647 BACKGROUND

• De Backer D, Orbegozo Cortes D, Donadello K, Vincent JL. Pathophysiology of microcirculatory dysfunction and the pathogenesis of septic shock. Virulence. 2014 Jan 1;5(1):73-9. doi: 10.4161/viru.26482. Epub 2013 Sep 25.

  PMID: 24067428 BACKGROUND

• Darmon M, Schortgen F, Vargas F, Liazydi A, Schlemmer B, Brun-Buisson C, Brochard L. Diagnostic accuracy of Doppler renal resistive index for reversibility of acute kidney injury in critically ill patients. Intensive Care Med. 2011 Jan;37(1):68-76. doi: 10.1007/s00134-010-2050-y. Epub 2010 Sep 23.

  PMID: 20862450 BACKGROUND

• Schnell D, Deruddre S, Harrois A, Pottecher J, Cosson C, Adoui N, Benhamou D, Vicaut E, Azoulay E, Duranteau J. Renal resistive index better predicts the occurrence of acute kidney injury than cystatin C. Shock. 2012 Dec;38(6):592-7. doi: 10.1097/SHK.0b013e318271a39c.

  PMID: 23042202 BACKGROUND

• Dewitte A, Coquin J, Meyssignac B, Joannes-Boyau O, Fleureau C, Roze H, Ripoche J, Janvier G, Combe C, Ouattara A. Doppler resistive index to reflect regulation of renal vascular tone during sepsis and acute kidney injury. Crit Care. 2012 Sep 12;16(5):R165. doi: 10.1186/cc11517.

  PMID: 22971333 BACKGROUND

• Haitsma Mulier JLG, Rozemeijer S, Rottgering JG, Spoelstra-de Man AME, Elbers PWG, Tuinman PR, de Waard MC, Oudemans-van Straaten HM. Renal resistive index as an early predictor and discriminator of acute kidney injury in critically ill patients; A prospective observational cohort study. PLoS One. 2018 Jun 11;13(6):e0197967. doi: 10.1371/journal.pone.0197967. eCollection 2018.

  PMID: 29889830 DERIVED

MeSH Terms

Conditions

Shock; Shock, Cardiogenic; Shock, Septic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Heleen M. Oudemans, Prof. Dr.

  Amsterdam UMC, location VUmc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 23, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 10, 2016

Record last verified: 2016-05

Locations

NL (1)