title: Levosimendan in daily intensive care practice--the experience of 15 centers. Background, methods and organization of the PORTLAND study.
abstract: BACKGROUND
  The LIDO and RUSSLAN trials showed that levosimendan was well tolerated and had a stronger hemodynamic effect than dobutamine and a positive impact on prognosis. There are, however, few data regarding its effectiveness and safety when used in an everyday clinical setting.
  
  
  OBJECTIVE
  To test the hypothesis that in day-to-day practice conditions levosimendan is both effective and safe for the treatment of decompensated heart failure (HF). This primary combined endpoint of effectiveness and safety was evaluated at 24 hours and 5 days after the beginning of the treatment.
  
  
  METHODS
  Prospective, multicenter, nonrandomized clinical trial with evaluations at baseline, 24 hours, 5 days, and 3 and 6 months. Follow-up for 6 months.
  
  
  METHODS
  The intensive care units of 15 cardiology or internal medicine departments.
  
  
  METHODS
  129 consecutive patients requiring inotropes due to decompensated systolic HF despite maximally tolerated oral therapy.
  
  
  METHODS
  24-hour infusion of levosimendan via a central or peripheral vein. MEASUREMENTS AND EVALUATION OF RESULTS: 1. Monitoring: Continuous ECG monitoring, non-invasive blood pressure, urinary output, oximetry. Invasive monitoring was not required. 2. Follow-up. Baseline evaluation: history, physical examination, ECG, 2D echocardiogram, hemogram, ionogram, liver and kidney function. 24-hour and 5-day evaluations: symptoms, physical examination, recording of medical therapy and previous 24-hour urinary output, ECG, hemogram, ionogram, liver and kidney function, and evaluation of arrhythmic episodes and heart rate and blood pressure trends in previous 24 hours. 3- and 6-month evaluations: number of hospital admissions and length of hospital stay due to HF, and mortality. 3. Evaluation of primary endpoint.
  
  
  RESULTS
  assessed by a clinical score including 2 subjective parameters (1. NYHA functional class, 2. patient self-evaluation symptom class) and 6 objective parameters (3. body weight, 4. pulmonary congestion, 5. previous 24-hour diuresis, 6. serum creatinine, 7. oral HF medication, 8. intravenous HF medication). Definition of clinical effectiveness: improvement in > or = 1 subjective parameters plus improvement in > or = 1 objective parameters, with all other parameters unchanged.
  
  
  RESULTS
  The therapy was judged safe in the absence of any serious adverse event with a probable or undetermined causal relationship with levosimendan. Primary endpoint evaluation: Patients reached the primary endpoint when levosimendan was both effective and safe according to the above definitions.
authors.affiliation: silvacardoso30@hotmail.com
authors.forename: J Silva
authors.initials: JS
authors.lastname: Cardoso
authors.forename: Jorge
authors.initials: J
authors.lastname: Ferreira
authors.forename: Edwiges Prazeres
authors.initials: EP
authors.lastname: de Sá
authors.forename: J Martins
authors.initials: JM
authors.lastname: de Campos
authors.forename: Cândida
authors.initials: C
authors.lastname: Fonseca
authors.forename: Nuno
authors.initials: N
authors.lastname: Lousada
authors.forename: J Ilídio
authors.initials: JI
authors.lastname: Moreira
authors.forename: Carlos
authors.initials: C
authors.lastname: Rabaçal
authors.forename: Albertino
authors.initials: A
authors.lastname: Damasceno
authors.forename: Ricardo
authors.initials: R
authors.lastname: Seabra-Gomes
authors.forename: Rafael
authors.initials: R
authors.lastname: Ferreira
authors.forename: Cassiano
authors.initials: C
authors.lastname: Abreu e Lima
mesh_terms: D003422:Critical Care; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D006835:Hydrazones / Q000627:therapeutic use*; D011446:Prospective Studies; D011724:Pyridazines / Q000627:therapeutic use*; D000077464:Simendan; D014665:Vasodilator Agents / Q000627:therapeutic use*
chemical_list: D006835:Hydrazones; D011724:Pyridazines; D014665:Vasodilator Agents; D000077464:Simendan