Overview

This trial is active, not recruiting.

Condition intra-dialytic hypotension
Treatments mannitol (20%), 0.9% saline
Phase phase 2
Sponsor Brigham and Women's Hospital
Start date May 2012
End date June 2016
Trial size 70 participants
Trial identifier NCT01520207

Summary

Kidney failure can result from a variety of conditions and can be temporary or permanent. Hemodialysis is available as a replacement treatment to perform the work that the kidneys normally do. However, the dialysis procedure can be associated with rapid changes in the composition of the blood - this may lead to changes in blood pressure and in turn reduced blood supply to important parts of the body. We aim to investigate if giving a medicine (called mannitol) during dialysis may be able to reduce the frequency of these low blood pressure events.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Placebo Comparator)
0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.
0.9% saline
1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
(Active Comparator)
Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.
mannitol (20%)
0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)

Primary Outcomes

Measure
Determine the efficacy of mannitol administration in reducing the frequency of intra-dialytic hypotension during the first three hemodialysis initiation sessions.
time frame: First three hemodialysis sessions (5 days)

Secondary Outcomes

Measure
Determine the effect of mannitol administration on the change in blood and urine biomarkers of acute kidney injury during the first three hemodialysis initiation sessions.
time frame: First three hemodialysis sessions (5 days)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Renal failure requiring intermittent hemodialysis initiation; adult patients aged over 18 years; written informed consent Exclusion Criteria: - Hyponatremia <130 mmol/L; acute myocardial infarction or stroke in previous 7 days; cardiac transplant; ventricular arrhythmia; unstable angina; use of pressors/midodrine; enrollment in conflicting research study; institutionalized individuals; pregnancy; prisoners; documented allergy to mannitol

Additional Information

Official title Pilot Study of Intravenous Mannitol During Hemodialysis Initiation to Reduce the Occurrence of Intra-dialytic Hypotension.
Principal investigator Sushrut S Waikar, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.