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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes

NCT01606787

Renal Cancer

COMPLETED PHASE3

Mannitol Use During Cadaveric Kidney Transplantation

NCT04705402

Renal Dialysis

UNKNOWN NA

Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults

NCT02822898

Healthy Adult Volunteers

COMPLETED PHASE4

Comparison of HES 130 in Balanced and in Unbalanced Solution

NCT01301469

Decreased and Nonspecific Blood Pressure Disorders and Shock

COMPLETED PHASE3

0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children

NCT01301274

Hyponatremia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intra-dialytic Hypotension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Mannitol (20%)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mannitol (20%)

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

Intervention Type DRUG

0.9% saline

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No