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PROPRANOLOL IN BURNT ADULT PATIENTS

Effects of the treatment with propranolol in the burnt adult intubated patient with sinusal tachycardia induced by burns. - PROPADB-01

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-001380-13-ES
Enrollment
Unknown
Registered
2014-04-25
Start date
2014-08-08
Completion date
Unknown
Last updated
2014-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BURNT-INDUCED SINUSAL TACHYCARDIA

Interventions

Trade Name: SUMIAL Product Name: PROPRANOLOL Pharmaceutical Form: Tablet INN or Proposed INN: PROPRANOLOL HIDROCLORURO CAS Number: 525-66-6 Concentration unit: mg milligram(s) Concentration type: equa

Sponsors

Abelardo Garcia De Lorenzo / Teresa Nuñez-Villaveiran
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Secondary Objective: o Assess 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). o Assess the effect of the treatment of sinusal tachycardia with propranolol on wound healing (graft intake and donor sites´ epithelialization). ;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 2. Daily until 2 weeks post injury

Secondary

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

Countries

Spain

Contacts

Public ContactTeresa

Teresa Nuñez-Villaveiran

tnuvi@hotmail.com+34917277211

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026