The Vasopressin in Pediatric Vasodilatory Shock Trial

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 69

Inclusion Criteria

Current inclusion criteria as of 20/12/2007:
1. Age: 1 month to 18 years, either sex
2. Vasodilatory shock: patient must be within 24 hours of fulfilling criteria 2.1. and 2.2.:
2.1. Fluid and catecholamine refractory shock: patient must fulfill criteria 2.1.1. and 2.1.2.:
2.1.1. Fluid administration (greater than or equal to 40 ml/kg crystalloid/colloid)
2.1.2. Minimum vasoactive infusion requirement for eligibility - either one of:
2.1.2.1. Dopamine greater than or equal to 10 µg/kg/min
2.1.2.2. Any dose of epinephrine, norepinephrine or phenylephrine
2.2. Clinical evidence of Vasodilation/Warm shock. These physical signs may be present at any time, including prior the institution of the vasoactive infusions listed in point 2.1.2.: patient must fulfill criteria 2.2.1., plus any two of the three criteria 2.2.2., 2.2.3. or 2.2.4. for eligibility:
2.2.1. Low diastolic blood pressure (BP) (as defined by diastolic BP less than half systolic BP value)
2.2.2. Tachycardia (as defined by heart rate [HR] greater than 2 SD for age)
2.2.3. Warm extremities
2.2.4. Flash capillary refill
3. Arterial line
4. Central venous line (a pulmonary artery catheter is optional)
5. Commitment of intensive care unit (ICU) team to full aggressive support
6. Informed consent: from parent or appropriate substitute decision-maker

Previous inclusion criteria:
1. Pediatric patients with vasodilatory shock, despite volume resuscitation and catecholamine pressor administration
2. Children greater than 1 month and less than 18 years of age, either sex

Exclusion Criteria

Added as of 20/12/2007:
1. Terminal illness (death anticipated in 24 hours, or withholding therapy considered)
2. Pregnancy
3. Known history of hypersensitivity to exogenous vasopressin
4. Cardiac Index less than or equal to 2.5 L/min/m^2 after fluid resuscitation (this is in the event that a formal cardiac index measurement has been performed, e.g. by Echo or Swan Ganz catheter)
5. Severe hyponatremia (serum sodium less than 125 mM) not responding to water restriction
6. Known history of vasospastic diathesis, e.g. Raynaud's phenomenon
7. Concurrent use of intravenous vasodilator agents: i.e. sodium nitroprusside, within 12 hours of phenoxybenzamine use
8. Patient who has received intravenous vasopressin or vasopressin analogue within 24 hours of eligibility
9. Diagnosis of syndrome of inappropriate antidiuretic hormone secretion (SIADH) or Diabetes Insipidus
10. Inability to obtain informed consent
11. Previous enrollment in the VIP study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Added as of 20/12/2007:<br>Time to vasoactive-free hemodynamic stability measured as time in hours from study drug administration to time when all vasopressor/inotropic agents are successfully discontinued.

Secondary Outcome Measures

Name	Time	Method
Added as of 20/12/2007:<br>1. Multiple organ dysfunction syndrome (MODS), measured by Delta PELOD - difference between MODS at study entry and worst value recorded during pediatric intensive care unit (PICU) stay<br>2. Organ Failure Free Days, measured up to 30 days post study drug administration<br>3. Mortality measaured up to 30 days post study drug administration