Protein C concentrate to restore physiological values in adult septic patients.
OBJECTIVE
To describe the efficacy and safety of protein C (PC) concentrate to restore physiological values in adult septic patients having clinical contraindications to activated PC.


METHODS
Case series (pilot study).


METHODS
Three adult ICUs of a University Hospital.


METHODS
Twenty adult patients affected by severe sepsis or septic shock with plasma values of PC < 50%.


METHODS
Patients were treated with PC concentrate (Ceprotin ((R))--Baxter) with a starting bolus followed by a continuous infusion for 72 h [3 IU/(kg h)].


RESULTS
PC activity, WBC, platelets, D: -Dimer, fibrinogen, PT, aPTT, AT III, lactate, Sepsis-related Organ Failure Assessment (SOFA), Disseminated Intravascular Coagulation (DIC) score, adverse events, and mortality were measured. Baseline plasma PC activity was 34.5 +/- 9.1%. PC concentrate normalized the PC activity in all patients within 48 h, and then remained stable for the following days. At baseline, several patients showed abnormal PT, aPTT, platelets values, and lactate levels. During the study period, there was a significant increase of platelets, fibrinogen, PT, AT III, and a significant decrease of D: -Dimer, aPTT, DIC score, and lactate. No adverse reactions (hemorrhage or thrombosis) were observed. Mortality at 28 days was 35%.


CONCLUSIONS
Our pilot study shows that the administration of PC concentrate to patients having contraindications to the treatment with activated PC was safe and possibly useful to control the coagulopathy triggered and sustained by sepsis. A randomized, double blind study in patients with severe sepsis and contraindications to activated PC administration would be advisable to state the safety and the possible role of this product in the treatment of severe sepsis.
Baratto
Fabio
F
Department of Pharmacology and Anesthesiology, University of Padua, Padua, Italy. fabio.baratto@sanita.padova.it
Michielan
Flavio
F
Meroni
Muzio
M
Dal Palù
Antonella
A
Boscolo
Annalisa
A
Ori
Carlo
C
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000378:metabolism / Q000627:therapeutic use*; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011486:Protein C / Q000378:metabolism / Q000627:therapeutic use*; D018805:Sepsis / Q000145:classification / Q000188:drug therapy* / Q000378:metabolism; D012720:Severity of Illness Index; D012772:Shock, Septic / Q000145:classification / Q000188:drug therapy* / Q000378:metabolism
D000925:Anticoagulants; D011486:Protein C