C1-inhibitor in patients with severe sepsis and septic shock: beneficial effect on renal dysfunction.
OBJECTIVE
To investigate the efficacy and the safety of the parenteral administration of C1-inhibitor to patients with severe sepsis or septic shock.


METHODS
Double blind, randomized, and placebo-controlled trial.


METHODS
Surgical and medical intensive care units of a tertiary care university hospital.


METHODS
Forty consecutive patients (20 C1-inhibitor/20 placebo) who entered the intensive care unit with severe sepsis or septic shock.


METHODS
C1-inhibitor intravenously in a 1-hr infusion, starting with 6000 IU, followed by 3000 IU, 2000 IU, and 1000 IU at 12-hr intervals, compared with placebo.


RESULTS
C1-inhibitor administration significantly increased plasma C1-inhibitor antigen and activity levels during days 1-4 (p <.007). Patients in the C1-inhibitor group had significantly lower serum creatinine concentrations on day 3 (p =.048) and 4 (p =.01) than placebo patients. Multiple organ dysfunction assessed by logistic organ dysfunction and sepsis-related organ failure assessment scores was less pronounced in patients treated with C1-inhibitor. Mortality rate was similar in both groups. There were no C1-inhibitor-related side effects.


CONCLUSIONS
C1-inhibitor administration attenuated renal impairment in patients with severe sepsis or septic shock.
Caliezi
Christoph
C
Central Laboratory of Hematology, University Hospital, Inselspital, Bern, Switzerland.
Zeerleder
Sacha
S
Redondo
Maurice
M
Regli
Bruno
B
Rothen
Hans-Ulrich
HU
Zürcher-Zenklusen
Regula
R
Rieben
Robert
R
Devay
Jan
J
Hack
C Erik
CE
Lämmle
Bernhard
B
Wuillemin
Walter A
WA
D000328:Adult; D000368:Aged; D001806:Blood Urea Nitrogen; D003174:Complement C1 Inactivator Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D050718:Complement C1 Inhibitor Protein; D003324:Coronary Artery Disease / Q000150:complications / Q000453:epidemiology; D003404:Creatinine / Q000097:blood; D015853:Cysteine Proteinase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D007668:Kidney / Q000098:blood supply / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D006435:Renal Dialysis; D051437:Renal Insufficiency / Q000209:etiology / Q000628:therapy; D012720:Severity of Illness Index; D012772:Shock, Septic / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D013203:Staphylococcal Infections / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D013223:Statistics as Topic; D013290:Streptococcal Infections / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D016019:Survival Analysis; D013557:Switzerland / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome
D003174:Complement C1 Inactivator Proteins; D050718:Complement C1 Inhibitor Protein; D015853:Cysteine Proteinase Inhibitors; D003404:Creatinine