Septic shock - low blood pressure due to infection
Conditions
Interventions
Product Name: argipressin (synthetic vasopressin)
Product Code: vasopressin
Pharmaceutical Form: Solution for infusion
Product Name: hydrocortisone (as sodium phosphate)
Product Code: Hydrocortisone
Sponsors
Imperial College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The target population is adult patients who require vasopressors for the management of sepsis despite fluid resuscitation. These patients will require management on the intensive care unit. Inclusion criteria will use the internationally-established consensus definitions of sepsis. In brief: • Fulfil 2/4 of the criteria of the systemic inflammatory response syndrome (SIRS) due to known or suspected infection within the previous 24 hours. The SIRS criteria are: (1) fever (>38° C) or hypothermia ( 90 beats per minute), (3) tachypnea (respiratory rate > 20 breaths per minute or PaCO2 12,000 cells/mm3, 10% immature [band] forms). • Hypotension despite adequate intravenous fluid resuscitation (minimum of 1 litre in the previous four hours). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patient has received a continuous infusion of vasopressors previously during this hospital admission (other than vasopressors used as emergency treatment to stabilise the patient during this episode). Vasopressors include noradrenaline, adrenaline, vasopressin, dopamine, metaraminol, phenylephrine. • Regular systemic corticosteroid therapy within the previous three months (this does not include inhaled steroid therapy). • End-stage renal failure • Known adrenal dysfunction / insufficiency. • Physician and team are not committed to full active care. • Patient who is terminally ill (death anticipated within 24 hours). • Patient is known to be pregnant. • Patient has known acute mesenteric ischemia. • Patient is being actively treated for an acute coronary syndrome. • Patient is known to have Raynaud's phenomenon, systemic sclerosis or other vasospastic diseases. • Patient is enrolled in another interventional trial that might interact with the study drugs. • Patients has a history of anaphylaxis to any study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess if corticosteroids increase circulating levels of vasopressin when used in the treatment of low blood pressure due to severe infection.;Secondary Objective: The secondary objectives are 1) To assess if corticosteroids increase the blood pressure response to vasopressin treatment 2) To act as feasibility study for a larger double-blind randomised controlled trial to examine the optimal timimg and interaction of drugs currently used in the management of low blood pressure due to severe infection.;Primary end point(s): Plasma vasopressin levels at 6-12 hours post study drug administration (eg hydrocortisone or placebo) between treatment groups. | — |
Countries
United Kingdom
Outcome results
None listed