The primary goal is investigate the method to achieve the most effective clearance od midmoecules in the first 6 hours of HVHF.The secondary goal is to determine to wich proportion the clearance of midmolecules due to proteinprecipitation declines…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As a marker for the clearance of smallmolecules, the concentration of
creatinin, urea and ADMA will be measured. As a marker for the clearance of the
midmolecules, the concentrations of β2-microglobuline en Interleukine-6 will be
measured.
The concentrations will be measured in the arterial blood, postfilter blood and
in the ultrafiltrate. We will measure the hematocrit in the bloodsamples.
Primary endpoint
Effectivity of the clearance of midmolecules, 15 minutes and 6 hours
after start HVHF, expressed as:
o Sieving coefficient
o Concentration filtrate* filtrateflow
Secondary outcome
Secundary endpoints
· Effectivity of the clearance of midmolecules, 12 hours after start HVHF
· Hemodynamics
· Metabolic control
· Other organfailure
Background summary
In patients with severe shock caused by sepsis or SIRS, high volume
hemofiltration during 6-8 hours has a possible positive effect on stabilisation
of the circulation and on survival. This effect is found in patients with
septic shock with or without renal failure. The circulation in patients after
cardiac arrest is often unstable due to a systemic inflammatory response.
Laurent compared patients after out of hospital cardiac arrest (ROSC < 60min)
treated with the standard therapy (therapeutic hypothermia was not common
practice in the study period), treated with HVHF and treated with HVHF and
hypothermia. There was a significant better survival in both HVHF groups
compared with standard treatment.
In the mentioned studies HVHF was given in dose variable from 4-8 lietrs/hr. In
the studies with the higher dosis, the substitutionsfluid are administered in
predilutionmodus.
The are large differences in the studies in dosis and in pre- or postdilution
modus. Dosis is therefore not comparable in the different studies.
Study objective
The primary goal is investigate the method to achieve the most effective
clearance od midmoecules in the first 6 hours of HVHF.
The secondary goal is to determine to wich proportion the clearance of
midmolecules due to proteinprecipitation declines in time.
Study design
Prospective randomized controlled trial with patients after cardiac arrest,
treated with hypothermia.
Patients will be randomized for HVHF with the conventional filter
(cellulose-triacetate, cut-off 60.000 D), high permeable cellulose-triacetate
filter (cut-off 100.000 D). In both groups patients will be ramdomized for
modus A, B or C
Modus Bloodflowml/min SubstitutionflowPOST ml/u SubstitutionflowPRE ml/u Extra
UF
A 240 4100
0 0
B 240 3000
1500 0
C 240 0
5900 0
Intervention
Hemofiltration with one of the earlier mentioned filters in 1 of the 3 modi (A,
B, C)
Study burden and risks
The studie patients will receive a CVVH catheter in the vena femoralis or vena
jugularis. Theoretically, complications of the insertion of a CVVH catheter are:
· arterial punction and hematoma
· Pneumothorax (only in the vena jugularis position)
The chance of these complications is small in our hospital.
During the first 24 hours, there will be blood and ultrafiltratesamplings. The
arterial bloodsamples will be drawn from the arterial catheter, already in
place in this catergory of patients. The patient will not notice this at all.
The postfilter bloodsamples will be taken at he side of the hemofiltration
machine, as will be done for the ultrafiltrate monsters. There is no burden for
the patient. Everey sampling of blood will take 19 ml of bloof=d from the
patient.
postbus 95500
1090 HM Amsterdam
Nederland
postbus 95500
1090 HM Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients with shock after cardiac arrest, treated with hypothermia
Exclusion criteria
no CVVH available
contra-indication nadroparin
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL22367.100.08 |
Other | R-08.31O/HEMOCLEAR |