Therapeutische Hypothermie (TH) - Repository of the LBI-HTA ...

4.1.7 Sepsis
Therapeutische Hypothermie, Zieltemperatur 32-35°C
Tabelle 4.1-7 zeigt die Charakteristika und Ergebnisse der eingeschlossenen
prospektiven, nicht-randomisierten, kontrollierten Studie zur therapeutischen
Hypothermie bei septischem Atemnot-Syndrom des Erwachsenen
(Acute Respiratory Distress Syndrome (ARDS)).
Tabelle 4.1-7: Included prospective, non-randomised, controlled trial of therapeutic hypothermia in patients with sepsis
Author, year, reference number Villar (1993) [28]
Country
ES/ CA
Sponsor
supported in part by Fondo de Investigaciones Sanitarias, Spain
Indication
severe septic adult respiratory distress syndrome (ARDS) unresponsive
to all other forms of available therapy (last resort)
Intervention
conventional treatment plus therapeutic hypothermia
- 32-35°C
- Hemotherm Unit (Cincinnati Sub-Zero Products, Inc.,
Ohio/US) or
- surface cooling by ice packs and fan
Control
conventional treatment
Study design
prospective, non-randomised, concurrent-controlled 18 study
Number of included patients, total (I vs C) 19 consecutive patients (9 vs 10)
Age of patients in years (I vs C), mean±SD 40±16 vs 39±11
Diagnosis (I vs C), n (%) - sepsis: 4/9 (44%) vs 4/10 (40%)
- trauma: 3/9 (33%) vs 3/10 (30%)
- aspiration pneumonia: 1/9 (11%) vs 2/10 (20%)
- bacterial pneumonia: 1/9 (11%) vs 1/10 (10%)
Mean temperature during hypothermia 33.7±0.6°C
Mean time on hypothermia 70±15h
Temperature measurement
pulmonary arterial catheter
Follow-up, months
NR
Loss to follow-up, n (%)
NR
Outcomes
Efficacy
Survival (I vs C), n (%)
3/9 (33%) vs 0/10 (0%), P