Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03658850
Other study ID # 2.603.927
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 1, 2018
Est. completion date March 10, 2020

Study information

Verified date April 2019
Source University of Sao Paulo
Contact André LN Gobatto, p.h.d
Phone +5571988646501
Email andregobatto@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 184
Est. completion date March 10, 2020
Est. primary completion date December 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hydrochlorothiazide 50Mg
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
Placebos
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

Locations

Country Name City State
Brazil Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary hypernatremia correction proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3 DAY 3
Secondary renal replacement therapy need to renal replacement therapy 6 months
Secondary mechanical ventilation incidence of mechanical ventilation 6 months
Secondary vasoactive drugs need for vasoactive drugs 6 months
Secondary mortality hospital mortality 6 months
Secondary serious adverse events incidence of serious adverse events 37/5000 incidence of serious adverse events 6 months
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Completed NCT03671447 - Enhanced Recovery After Intensive Care (ERIC) N/A
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed NCT04239209 - Effect of Intensivist Communication on Surrogate Prognosis Interpretation N/A
Completed NCT05531305 - Longitudinal Changes in Muscle Mass After Intensive Care N/A
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Completed NCT02916004 - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients. N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed NCT04479254 - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study) N/A
Recruiting NCT04475666 - Replacing Protein Via Enteral Nutrition in Critically Ill Patients N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Recruiting NCT02922998 - CD64 and Antibiotics in Human Sepsis N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Completed NCT02899208 - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients? N/A
Recruiting NCT02163109 - Oxygen Consumption in Critical Illness