ACTRN12606000087550
Completed
Phase 1
The haemodynamic effects of Vasopressin in early hyperdynamic septic shock
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Prince of Wales Hospital
- Enrollment
- 25
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Informed consent obtained 2\. PiCCO and/or a pulmonary artery catheter in situ. 3\. Severe sepsis and septic shock diagnosed less than 24 hours prior to enrollment. 4\. Severe sepsis will be defined as the presence of clinical and laboratory evidence suggestive of infection induced systemic inflammatory response to a possible infection with acute organ dysfunction. Septic shock will be defined as severe sepsis associated with a MAP \< 70 mm Hg for a minimum of 30 minutes (or a fall in systolic blood pressure (SBP) \> 40 mm Hg for patients with pre\-existing hypertension) despite optimal fluid resuscitation or the requirement for vasoconstrictor support for at least 2 hours to maintain a MAP \>70 mm Hg where vasoconstrictor support is defined as noradrenaline \> 0\.05 ug/kg/min, adrenaline \> 0\.05 ug/kg/min or dopamine \> 3 ug/kg/min Optimal fluid resuscitation will be defined as either a global end\-diastolic volume index \>750 mL/m2 and an intra\-thoracic blood volume \> 900 mL/m2 as measured by PiCCO or a pulmonary artery occlusion pressure (PAOP) of 15 to 18 mmHg and /or a sustained (\> 30 minutes) rise in PAOP of \> 3 mm Hg after a 5 mLkg\-1 blood product or colloid fluid challenge over 20 minutes. 5\. CI \> 3\.5 L/min/m2 6\. A dedicated central venous line lumen for infusion of study drug.
Exclusion Criteria
- •1\. Females of child bearing age – no pregnancy test available2\. Age \< 18 years3\. Vasoconstrictor support for less than 2 hours duration (vasoconstrictor support as defined in inclusion criteria) 4\. Shock refractory to noradrenaline, defined as a MAP of \< 70 mm Hg associated with a noradrenaline infusion rate of \> 1\.0 ug/kg/min.5\. Moribund pts unlikely to survive6\. Previously documented significant non\-revascularised coronary artery disease i.e. any coronary arterial occlusion of greater than 70%.7\. New York Heart Association classification III or IV or pre\-morbid LVEF of less than 30%.8\. Recent MI \< 3 months prior to enrolment or recent functional class II Angina.9\. Acute ECG or biochemical evidence of myocardial ischaemia. 10\. C.I. of less than 3\.5 l/min/m2 as measured by PiCCO or pulmonary artery catheter. 11\. Previously documented cirrhosis and/or severe liver dysfunction (INR \>2, bilirubin \>50\) or clinical evidence of portal hypertension.12\. The presence of ischaemic gut (documented or high suspicion) or abdominal angina.13\. Chronic renal failure requiring dialysis (i.e. haemo\- or peritoneal).14\. Irreversible medical condition with imminent death (\< 24 hours) or lack of commitment to full support (mechanical ventilation, haemodialysis etc) 15\. Chemotherapy in last 30 days.16\. Significant steroid use of \>1mg/kg for 3 days or more in the last 7 days prior to admission to ICU.17\. Consent refused or revoked.18\. Allergy to iodine.
Outcomes
Primary Outcomes
Not specified
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