Septic Shock Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 92 |
Est. completion date | February 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | VU Medical Center | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
VU University Medical Center |
Netherlands,
Basile DP, Anderson MD, Sutton TA. Pathophysiology of acute kidney injury. Compr Physiol. 2012 Apr;2(2):1303-53. doi: 10.1002/cphy.c110041. Review. — View Citation
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. — View Citation
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. Review. — View Citation
Dewitte A, Coquin J, Meyssignac B, Joannès-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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | renal resistive index (RRI) | 1 week | No | |
Secondary | Creatine clearance (marker of GFR) | 1 week | No |
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