CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Mannitol (20%) +1 moredrug
Likely dose
Mannitol (20%) 0.25gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01520207
NCT01520207Phase 2Completed
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Pilot Study of Intravenous Mannitol During Hemodialysis Initiation to Reduce the Occurrence of Intra-dialytic Hypotension.

Brigham and Women's Hospital·interventional·Posted Jan 27, 2012·Updated Jan 30, 2019

In Brief

A Phase 2 clinical trial evaluating Mannitol (20%) and 0.9% saline for Intra-dialytic Hypotension. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntra-dialytic Hypotension
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 27, 2012
Enrollment StartMay 1, 2012
Primary CompletionJul 1, 2016
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 14.4 years ago

Interventions

Mannitol (20%)drug

0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)

0.9% salinedrug

1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment