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Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension

Primary Purpose

Intra-dialytic Hypotension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mannitol (20%)
0.9% saline
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intra-dialytic Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo group: (0.9% normal saline)

Intervention: intravenous mannitol (20%)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions.
SBP decline during first three sessions

Secondary Outcome Measures

Full Information

First Posted
January 25, 2012
Last Updated
January 14, 2019
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01520207
Brief Title
Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension
Official Title
Pilot Study of Intravenous Mannitol During Hemodialysis Initiation to Reduce the Occurrence of Intra-dialytic Hypotension.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-dialytic Hypotension

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group: (0.9% normal saline)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Intervention: intravenous mannitol (20%)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mannitol (20%)
Intervention Description
0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Intervention Description
1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
Primary Outcome Measure Information:
Title
Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions.
Description
SBP decline during first three sessions
Time Frame
First three hemodialysis sessions (5 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sushrut S Waikar, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital, Harvard Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Finnian R Mc Causland, MB, MMSc
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31040088
Citation
Mc Causland FR, Claggett B, Sabbisetti VS, Jarolim P, Waikar SS. Hypertonic Mannitol for the Prevention of Intradialytic Hypotension: A Randomized Controlled Trial. Am J Kidney Dis. 2019 Oct;74(4):483-490. doi: 10.1053/j.ajkd.2019.03.415. Epub 2019 Apr 27.
Results Reference
derived

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Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension

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