NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	severe sepsis and septic shock
Date of first enrollment	23/02/2010
Target sample size	35
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : GCH-01 INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : continuous hemodiafiltration (CHDF)

Outcome(s)

Primary Outcome	28 days survival rate after initiation
Secondary Outcome	(1) serum BUN, Cre (2) accumulated UF volume

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 80age old
Gender	Both
Include criteria	(1) sepsis (2) blood lactate concentration>36mg/dL (4.0mmol/L)
Exclude criteria	(1) unidentified patients (2) pregnant women, nursing mother, patients may be or in doubt of pregnancy (3) patients are expected to die within 3 days from enrollment (4) patients with the anamnesis of the anaphylactoid reactions which are attributable to previous hemodialyzer/ hemofilter use (5) patients who have not passed 24 hours following an episode of uncontrollable bleeding