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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Sushrut S Waikar, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01520207
First received: January 25, 2012
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Intra-dialytic Hypotension
Drug: Mannitol (20%)
Drug: 0.9% saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Pilot Study of Intravenous Mannitol During Hemodialysis Initiation to Reduce the Occurrence of Intra-dialytic Hypotension.

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo group: (0.9% normal saline)
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
1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
Active Comparator: Intervention: intravenous mannitol (20%)
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%)
0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520207

Contacts
Contact: Sushrut S Waikar, MD, MPH 617-732-8473 swaikar@partners.org
Contact: Finnian R Mc Causland, MB, MMSc 617-732-6432 fmccausland@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Sushrut S Waikar, MD MPH         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Sushrut S Waikar, Assistant Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01520207     History of Changes
Other Study ID Numbers: NCT01520207
Study First Received: January 25, 2012
Last Updated: May 14, 2014
Health Authority: United States: Partners Institutional Review Board

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014