Shock, Vasoplegic Syndrome
Conditions
Keywords
shock, distributive, angiotensin II, renin, shock, septic, vasoplegia
Brief summary
Shock is a life-threatening condition which can cause multiple organ failure and even death. One characteristic of shock is low blood pressure which is managed with drugs called vasopressors. Most frequently used vasopressors are noradrenaline, vasopressin and recently also angiotensin II. Angiotensin II is present in the body and has a physiological role in maintaining blood pressure in healthy persons. Renin is an enzyme and a key factor in angiotensin II production in the body. In patients with shock, there is a lack of angiotensin II and an excess of renin in the body. Due to the literature renin has the potential to be a marker of severity of shock. Synthetic angiotensin II is used in patients with shock in whom we cannot normalize the blood pressure with noradrenaline and vasopressin. Regarding scientific data, the use of synthetic angiotensin II reduces the dose of noradrenaline and vasopressin and the incidence of acute kidney injury. The aim of our study is to find out what is the relation between the concentration of renin before and 6 hours after the start of using angiotensin II in patients with shock and their clinical outcome. Since not all patients with shock are responding to angiotensin II, the aim of our study is also to find out which patients could benefit most from synthetic angiotensin II.
Detailed description
In patients with distributive shock (≥18 years) with noradrenaline at least 0,3 mcg/kg/min and vasopressin 0,03 IE/min not achieving an appropriate mean arterial pressure (65-85 mmHg) despite fluid resuscuitation an angiotensin II infusion will be started at 20 ng/kg/min and after that adjusted to a max dose of 40 ng/kg/min if needed. Before the infusion and 6 hours after the start of angiotensin II infusion a blood sample will be drawn to determine the renin concentration. The primary outcome will be organ failure free days and ICU free days. Secondary outcome will be the need for vasopressors, dialysis, mechanical ventilation, trend of renin concentration.
Interventions
None listed
Sponsors
University Medical Centre Maribor
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* patients with distributive shock lasting \< 72 hours * a goal mean arterial pressure (65-85 mmHg) not achieved despite optimal fluid resuscitation (30 ml/kg cristalloid) and an infusion of at least noradrenaline 0.3 mcg/kg/min and vasopressin 0.03 IE/min * the patient did not get angiotensin II before * predicted survival is \>24h * no limitations for active treatment
Exclusion criteria
* burns \>20% body area * acute coronary syndrome * bronchospasm * liver disease (MELD ≥30) * severe acute bleeding (need for 4 or more units of concentrated erythrocyte) * acute mesenteric ischemia * aortic dissection * leucopenia \<1000/mm3 * pregnancy * Raynaud disease, systemic sclerosis, vasospastic disease * active venous or arterial thromboembolic disease * the need for daily dose of hydrocortisone 500 mg or more * ECMO * cardiac index \<l/min/m2 (defined by echocardiography or invasive methods) * central venous oxygen saturation (SCVO2) \>70%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association between 0-6-hour change in relative renin ratio (ΔRRR = RRR6h - RRR0h) and 28-day organ failure-free days (without vasopressors, mechanical ventilation and renal replacement therapy (RRT)) | 0-28 days | days alive without the need of vasopressors, ventilators, or dialysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between ΔRRR and 28-day ICU free days | 0-28 days | 28 minus ICU stay |
| Association between ΔRRR and vasopressor free days | 0-28 days | time without vasopressors |
| Association between ΔRRR and cumulative dose of vasopressors expressed in norepinephrine equivalent dose (NED) | 0-28 days | cumulative dose of vasopressors expressed in norepinephrine equivalent dose (NED) |
| Association between ΔRRR and the RRT free days | 0-28 days | 28 minus days with RRT (renal replacement therapy) |
| Association between ΔRRR and invasive mechanical ventilation free days | 0-28 days | 28 minus days with invasive mechanical ventilation |
| Determination of responders and nonresponders based on calculation of the ratio between change in MAP between 0 and 1 hours of protocol to the change in total vasopressor NED between 0 and 1 hours of protocol. | 0-1 hour | — |
| Comparison of the prognostic performance of renin and lactate at 0 and 6 hours for 28-day mortality. | 0-6 hour | — |
| product ( [renin] x [lactate]) at baseline and 6 hours after start of angiotensin II infusion | baseline - just before start of angiotensin II infusion; 6 hours - 6 hours after start of angiotensin II infusion | Determination if the product ( \[renin\] x \[lactate\]) at baseline and 6 hours after start of angiotensin II infusion predicts 28-day organ failure free days, mortality, cumulative dose of vasopressors expressed in NED, renal replacement therapy and mechanical ventilation |
| Change in total norepinephrine-base dose equivalen (NED) at baseline and 1 hour predicts mortality | change in norepinephrine-base dose equivalent (NED) from start of angiotensin II infusion (baseline) and 1 hour after start of angiotensin II infusion | Change in norepinephrine-base dose equivalent (NED) at baseline and 1 hour predicts mortality |
Countries
Slovenia
Contacts
CONTACTAndreja Möller Petrun, PhD
STUDY_CHAIRAndreja Möller Petrun, PhD
University Medical Centre Maribor
Outcome results
None listed