Terlipressin for the treatment of refractory hypotension in patients otherwise ready for discharge.

Phase 1

• Conditions: Hypotension; Cardiovascular disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12624000364572
• Lead Sponsor: Sir Charles Gairdner Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-28
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Adults (>=18 years of age)
•Admitted to the SCGH ICU
•Requiring IV vasopressors (metaraminol, noradrenaline, central or peripheral) for more than 6 hours
•Rate of less than 10 mcg/min of noradrenaline

Exclusion Criteria

•Inadequate tissue oxygenation ((lactate > 2 mmol plus any acute rise in creatinine by at least 50 mmol/l within 24 hours), or acute rise in ALT > 3x)
•Mesenteric ischaemia or recent laparotomy
•Hypovolemic shock (uncorrected) or hypotension due to adrenal insufficiency (if a serum cortisol assessment had been performed for clinical reasons
•Severe organic heart disease (EF < 35%, recent MI or heart failure (last month))
•Uncontrolled hypertension
•Conditions that may be exacerbated by fluid overload (chronic renal failure, cardiac disease)
•Uncorrected hypokalemia (<3) or hypomagnesemia (< 0.6) as may prolong QT interval
•Hyponatraemia – Na <130
•Women between the ages of 18-55 who have not had a surgical hysterectomy will only be eligible or for inclusion if they have a negative urine pregnancy test.
•Pregnancy testing will not need to be repeated if there is a documented negative urine pregnancy test that was obtained within 7 days prior to starting study drug, provided the woman was an ICU inpatient throughout that period of time.

Study & Design

• Study Type: Interventional
• Study Design: Not specified