Back to resultsSafety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients (HYDRA)
Primary Purpose
Hypernatremia, Critical Illness
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Hydrochlorothiazide 50Mg
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Hypernatremia focused on measuring hypernatremia, Critical care
Eligibility Criteria
Inclusion Criteria:
- hospitalized for intensive care,
- Over 18 years of age,
- Two serum sodium measurements above 145 mEq / L (with no pre-determined interval between them),
- Mean arterial pressure greater than 65mmHg
Exclusion Criteria:
- Absence of consent to participate in the study
- Cardiac index below 2.5L / min / m2 OR signs of ineffective circulation (capillary filling time greater than 2 seconds, cold or sticky skin) OR arterial lactate> 4mMol / L.
- Use of vasopressors at doses greater than 0.1 mcg / kg / min of noradrenaline or with initiation or increase of dose within less than one hour before inclusion in the study.
- Unavailable enteral route.
- Use of hydrochlorothiazide in the last 7 days of ICU admission.
- History of allergy or intolerance to hydrochlorothiazide or other thiazides.
- Nephrogenic Diabetes Insipidus.
- Renal impairment KDIGO 3
- Indication of renal replacement therapy.
- Acute neurological insult.
- Heart failure American Heart Association classification (AHA), class D.
- Liver cirrhosis Child-Pugh C.
- Pregnant women
- Exclusive palliative care
- Dying, with expected survival less than 48 hours
Sites / Locations
- Hospital das Clinicas da Faculdade de Medicina da Universidade de São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
the experimental group will receive one tablet of hydrochlorothiazide in the presentation of 50mg or equivalent enteral solution every 12h (total of 100mg per day) enterally for 3 days.
placebo group will receive one tablet or equivalent volume of enteral solution of inert substance
Outcomes
Primary Outcome Measures
hypernatremia correction
proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3
Secondary Outcome Measures
renal replacement therapy
need to renal replacement therapy
mechanical ventilation
incidence of mechanical ventilation
vasoactive drugs
need for vasoactive drugs
mortality
hospital mortality
serious adverse events
incidence of serious adverse events 37/5000 incidence of serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03658850
Brief Title
Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients
Acronym
HYDRA
Official Title
Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 10, 2019 (Anticipated)
Study Completion Date
March 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
HYDRA is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypernatremia, Critical Illness
Keywords
hypernatremia, Critical care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
the experimental group will receive one tablet of hydrochlorothiazide in the presentation of 50mg or equivalent enteral solution every 12h (total of 100mg per day) enterally for 3 days.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
placebo group will receive one tablet or equivalent volume of enteral solution of inert substance
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide 50Mg
Intervention Description
for the experimental group received a hydrochlorothiazide tablet on presentation of 50mg or equivalent enteral solution every 12h (total of 100mg per day) enterally on day 0 (D0) until day 3
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
for the placebo group will receive one tablet or equivalent volume of enteral solution of inert substance, identical to the hydrochlorothiazide presentations, every 12 hours until day 3
Primary Outcome Measure Information:
Title
hypernatremia correction
Description
proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3
Time Frame
DAY 3
Secondary Outcome Measure Information:
Title
renal replacement therapy
Description
need to renal replacement therapy
Time Frame
6 months
Title
mechanical ventilation
Description
incidence of mechanical ventilation
Time Frame
6 months
Title
vasoactive drugs
Description
need for vasoactive drugs
Time Frame
6 months
Title
mortality
Description
hospital mortality
Time Frame
6 months
Title
serious adverse events
Description
incidence of serious adverse events 37/5000 incidence of serious adverse events
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hospitalized for intensive care,
Over 18 years of age,
Two serum sodium measurements above 145 mEq / L (with no pre-determined interval between them),
Mean arterial pressure greater than 65mmHg
Exclusion Criteria:
Absence of consent to participate in the study
Cardiac index below 2.5L / min / m2 OR signs of ineffective circulation (capillary filling time greater than 2 seconds, cold or sticky skin) OR arterial lactate> 4mMol / L.
Use of vasopressors at doses greater than 0.1 mcg / kg / min of noradrenaline or with initiation or increase of dose within less than one hour before inclusion in the study.
Unavailable enteral route.
Use of hydrochlorothiazide in the last 7 days of ICU admission.
History of allergy or intolerance to hydrochlorothiazide or other thiazides.
Nephrogenic Diabetes Insipidus.
Renal impairment KDIGO 3
Indication of renal replacement therapy.
Acute neurological insult.
Heart failure American Heart Association classification (AHA), class D.
Liver cirrhosis Child-Pugh C.
Pregnant women
Exclusive palliative care
Dying, with expected survival less than 48 hours
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
André LN Gobatto, p.h.d
Phone
+5571988646501
Email
andregobatto@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André LN Gobatto, p.h.d
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
André LN Gobatto, M.D.
Phone
+5511991796501
Email
andregobatto@gmail.com
First Name & Middle Initial & Last Name & Degree
André LN Gobatto, M.D.
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients
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