Vasopressin and Corticosteroids in Septic Shock

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 (< 36° C),
(2) tachycardia (heart rate > 90 beats per minute),
(3) tachypnea (respiratory rate > 20 breaths per minute or PaCO2 < 4.3 kPa) or need for mechanical ventilation,
(4) abnormal leukocyte count (> 12,000 cells/mm3, < 4000 cells/mm3, or > 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

• 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.