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A pilot single-centre double-blind randomised controlled trial of the effect of centhaquine on stroke volume in the treatment of vasodilatory hypotension in adults admitted to the intensive care unit

A pilot single-centre double-blind randomised controlled trial of centhaquine in the treatment of vasodilatory hypotension in adults admitted to the intensive care unit

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000384550
Enrollment
0
Registered
2024-04-03
Start date
2024-10-07
Completion date
Unknown
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Current pharmacotherapy options of haemodynamic support in critically ill patients with vasodilatory hypotension are limited. Centhaquine is a novel agent that has a dual action on the sympathetic system and may helped in the management of hypotensive states. We hypothesise that, compared to placebo, centhaquine will be associated with higher stroke volume, higher central venous pressure, higher mean arterial pressure, and lower vasopressor agent use over six hours after initiation of the study infusion. We plan to enrol 18 adult patients.

Interventions

Centhaquine is to be administered at a dose of 0.01 mg/kg body weight as an Intravenous infusion over 1 hour in 100 ml 0.9% sodium chloride (NaCl) with adherence to the intervention performed via electronic medical record review.

Sponsors

Austin Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults aged equal to or greater than 18 years Vasopressor dependent hypotension (vasopressor therapy to maintain a mean arterial pressure greater than 65 mmHg) Cardiac index > 2.3 litres per minute per meters squared or central venous oxygen saturation > 70 percent Central venous access and an arterial line present Expected to require vasopressor support for at least 24 hours Informed consent provided by the patient or medical treatment decision maker

Exclusion criteria

Cardiac surgery patients Suspected cardiogenic shock Greater than 24 hours continuous vasoactive therapy prior to enrolment Chronic haemodialysis or peritoneal dialysis Expected survival less than 24 hours Suspected or confirmed pregnancy Previously enrolled into the this trial

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026