NCT01520207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 19, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

4.2 years

First QC Date

January 25, 2012

Results QC Date

September 20, 2017

Last Update Submit

January 14, 2019

Conditions

Intra-dialytic Hypotension

Outcome Measures

Primary Outcomes (1)

  • 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

    First three hemodialysis sessions (5 days)

Study Arms (2)

Placebo group: (0.9% normal saline)

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.

Drug: 0.9% saline

Intervention: intravenous mannitol (20%)

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.

Drug: Mannitol (20%)

Interventions

Mannitol (20%)DRUG

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

Intervention: intravenous mannitol (20%)
0.9% salineDRUG

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

Placebo group: (0.9% normal saline)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal failure requiring intermittent hemodialysis initiation; adult patients aged over 18 years; written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • Curtis KA, Waikar SS, Mc Causland FR. Higher NT-proBNP levels and the risk of intradialytic hypotension at hemodialysis initiation. Hemodial Int. 2024 Jan;28(1):77-84. doi: 10.1111/hdi.13125. Epub 2023 Oct 24.

    PMID: 37875429DERIVED

  • 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.

    PMID: 31040088DERIVED

MeSH Terms

Interventions

MannitolSaline Solution

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Finnian Mc Causland
Organization
Brigham and Women's Hosptial
fmccausland@partners.org
6177326432

Study Officials

  • Sushrut S Waikar, MD, MPH

    Brigham and Women's Hospital, Harvard Medical School

    PRINCIPAL INVESTIGATOR

  • Finnian R Mc Causland, MB, MMSc

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Harvard Medical School

Study Record Dates

First Submitted

January 25, 2012

First Posted

January 27, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2016

Study Completion

December 1, 2018

Last Updated

January 30, 2019

Results First Posted

October 19, 2017

Record last verified: 2019-01

Locations

US(1)