NCT03658850

Brief Summary

HYDRA is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

May 22, 2018

Last Update Submit

April 27, 2019

Conditions

HypernatremiaCritical Illness

Keywords

hypernatremiaCritical care

Outcome Measures

Primary Outcomes (1)

  • hypernatremia correction

    proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3

    DAY 3

Secondary Outcomes (5)

  • renal replacement therapy

    6 months

  • mechanical ventilation

    6 months

  • vasoactive drugs

    6 months

  • mortality

    6 months

  • serious adverse events

    6 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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.

Drug: Hydrochlorothiazide 50Mg

Control

PLACEBO COMPARATOR

placebo group will receive one tablet or equivalent volume of enteral solution of inert substance

Drug: Placebos

Interventions

Hydrochlorothiazide 50MgDRUG

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
PlacebosDRUG

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

Control

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

HypernatremiaCritical Illness

Interventions

Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • André LN Gobatto, p.h.d

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

André LN Gobatto, p.h.d

CONTACT

+5571988646501andregobatto@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2018

First Posted

September 5, 2018

Study Start

October 1, 2018

Primary Completion

December 10, 2019

Study Completion

March 10, 2020

Last Updated

April 30, 2019

Record last verified: 2019-04

Locations

BR(1)