PROPRANOLOL IN BURNT ADULT PATIENTS

Conditions: BURNT-INDUCED SINUSAL TACHYCARDIA
Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

Registration Number: EUCTR2014-001380-13-ES

Lead Sponsor: Abelardo Garcia De Lorenzo / Teresa Nuñez-Villaveiran

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Burnt patients with mechanical ventilation, between 14 and 75 years of age, with sinusal tachycardia (>100 bpm), admitted to our Burns Unit during an estimated period of 2 years.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

Patients in whom beta-blockers are contraindicated.
Patients with beta-blocker treatment before admission.
Unsigned Informed Consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: oAssess the effect of the treatment of sinusal tachycardia with propranolol in the morbidity and mortality of the burned patient (sepsis, infections, necessity of inotropic agents, burn wound colonization). <br>oAssess the effect of the treatment of sinusal tachycardia with propranolol on wound healing (graft intake and donor sites´ epithelialization). <br>;Main Objective: Assess the effect of treatment with propranolol in the adult burnt patient with sinusal tachycardia by measuring its effect on the resting energy expenditure. ;Primary end point(s): Resting energy expenditure and respiratory quotient (VCO2/VO2);Timepoint(s) of evaluation of this end point: 1.At the time of admission<br>2. Daily until 2 weeks post injury

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -HR and BP<br>-Caloric intake<br>-Need of sedoanalgesia<br>-Inotropic agents<br>-Days of inotropic agents administration<br>-Number of surgical procedures needed <br>-Healing time for donor sites<br>-Graft intake 5 days after surgery<br>-Burn wound colonization<br>-Burn wound infection or donor site infection<br>-Other infections<br>-Sepsis<br>-Mortality<br>;Timepoint(s) of evaluation of this end point: 1.At the time of admission<br>2. Daily until 2 weeks post injury