The Effect of Vasopressor Therapy on Renal Perfusion in Septic Shock

ConditionsSeptic Shock Acute Kidney Injury

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorKing's College Hospital NHS Trust

About this trial

Acute kidney injury (AKI) is a common complication of septic shock and together these conditions carry a high mortality risk. In septic patients who develop severe AKI renal cortical perfusion is deficient despite normal macrovascular organ blood flow. This intra-renal perfusion abnormality may be amenable to pharmacological manipulation, which may offer mechanistic insight into the pathophysiology of septic AKI. The aim of the current study is to investigate the effects of vasopressin and angiotensin II on renal microcirculatory perfusion in a cohort of patients with septic shock.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Within 48 hours of intensive care admission

Evidence of suspected or confirmed infection

Sequential Organ Failure (SOFA) score increase of 2 or more (assuming a baseline of 0 if no previous measures)

Requirement for norepinephrine infusion as the sole vasopressor agent in a dose of >0.1mcg/kg/min

Disqualifiers

Known intolerance to Sonovue™ contrast medium, vasopressin or angiotensin II

Patients receiving other vasoactive drugs in addition to norepinephrine

Patients with known chronic kidney disease (CKD) stage 4 or 5 (baseline glomerular filtration rate (GFR) <30mls/min)

Patients receiving extra corporal membrane oxygenation (ECMO)

Trial design

Design model

Parallel

Treatments tested in this trial

Angiotensin II
Drug
Angiotensin II infusion
Vasopressin
Drug
Vasopressin infusion
Norepinephrine
Drug
Standard care vasopressor therapy, norepinephrine infusion

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: Angiotensin II InfusionExperimental treatment 2 interventions

Group B: Vasopressin InfusionExperimental treatment 2 interventions

Group C: Norepinephrine InfusionActive comparator 1 intervention

Trial outcomes

Primary outcomes

Cortical mean transit time (mTT) measured in seconds

Contrast enhanced ultrasound measure of renal cortical tissue blood flow

Time frame

Measured at +24 hours following study vasopressor infusion starting

Secondary outcomes

Cortical mean transit time (mTT) measured in seconds

Contrast enhanced ultrasound measures of renal cortical tissue blood flow

Time frame

Measured at +1 hour and +24 hours following study vasopressor infusion starting

Cortical perfusion index (PI) measured in arbitrary units

Contrast enhanced ultrasound measures of renal cortical tissue blood flow

Time frame

Measured at +1 hour and +24 hours following study vasopressor infusion starting

Cortical wash in rate (WiR) measured in arbitrary units

Contrast enhanced ultrasound measures of renal cortical tissue blood flow

Time frame

Measured at +1 hour and +24 hours following study vasopressor infusion starting

Urinary oxygen tension (pO2) across 24 hours study period measured in millimetres of mercury (mmHg)

Mean urinary pO2

Time frame

Across 24 hours study period

Other outcomes

Perfused vessel density (PVD) measured in millimetres per square millimetre

Incident dark field video microscopy measures of the systemic microcirculation

Time frame

Measured at +1 hour and +24 hours following study vasopressor infusion starting

Microvascular flow index (MFI) (unitless score from 0 to 3 where 3 is the value see in health).

Incident dark field video microscopy measures of the systemic microcirculation

Time frame

Measured at +1 hour and +24 hours following study vasopressor infusion starting

Syndecan 1, angiopoietin 1 & 2, Interleukin 6 & 8 (IL-6, IL-8) and tissue necrosis factor (TNF). All measured in nanograms per millilitre (ng/ml)

Biomarker analysis - markers of inflammation and endothelial activation/function

Time frame

Measured at baseline and +24 hours following study vasopressor infusion starting

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College Hospital NHS Trust

Lead sponsor

European Society of Intensive Care Medicine

Collaborator

Royal Centre for Defence Medicine

Collaborator

Source ClinicalTrials.gov

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