Study of the Effect of Intradialytic Vasopressin on Chronic Hypertension in Patients With End Stage Renal Disease

What Was Tested

In this phase 2 trial, researchers set out to test Vasopressin.

It had three arms (groups): one (active comparator), one (active comparator) and Group 3: Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Data on the original subjects is complete and results are posted.

The data from this study will be used to design and conduct additional study enrollment/extension (24 subjects) in order to make some initial statistical comparisons between groups, which will help establish greater confidence in their novel method for controlling blood pressure in dialysis patients.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: End Stage Renal Disease on Hemodialysis greater than 3 months. Hypertension (Predialysis systolic blood pressure (SBP) greater than 140 mmHg, averaged over preceding 6 dialysis treatments). Stable dry weight over preceding 6 dialysis treatments.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: age less than 18 years; predialysis systolic blood pressure (sbp) greater than 200 mmhg or diastolic blood pressure (bp) \>110; long qtc syndrome (an electrocardiogram (ecg) will be performed if unavailable within the last 3 months).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Vasopressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-10 with completion listed for 2018-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Mean Interdialytic 44-hour Ambulatory Systolic Blood Pressure Over a 2 Week Follow-up Period (time frame: Baseline and Two Weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Vasopressin in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Vasopressin compound page, all human trials.