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.
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.
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