Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03842657 |
| Other study ID # |
RC31/17/0451 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
July 5, 2019 |
| Est. completion date |
September 13, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
University Hospital, Toulouse |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Critically ill patients have a high risk of bleeding but also require prolonged intermittent
dialysis. Thus, a heparin-free easy-to-use alternative type of anticoagulation within the
dialysis circuit is required. In a non-comparative study, heparin-free regional citrate
anticoagulation of the dialysis circuit using a calcium-free citrate-containing dialysate,
with calcium reinjected according to ionic dialysance, was considered as safe and efficient.
The aim of this study is to confirm the superiority of this approach compared to a
anticoagulation based on heparin-grafted membrane.
Description:
Critically ill patients have a high risk of bleeding but also require prolonged intermittent
dialysis. Several modalities are used for heparin-free dialysis sessions. Iterative saline
infusion and heparin-grafted membranes are easy to use and remain the standards-of-care for
high-risk bleeding situations but efficiency is low: success rates from hemodialysis sessions
range from 50% to 65% and 50% to 75%, respectively. Furthermore, sessions that last for
greater than 240 minutes are rarely achievable and can be problematic when ensuring an
adequate dose of dialysis and a negative water balance in patients who cannot tolerate a high
ultrafiltration rate. Thus, the development of alternative regional anticoagulation methods
is needed urgently to improve intermittent hemodialysis (IHD) in critically ill patients and
to avoid systemic anticoagulation in patients with a high risk of bleeding.
An easy way to provide citrate inside the filter, to lower iCa below 0.45 mmol/L could be to
use diffusive influx from the dialysate. It has been demonstrated recently that the use of
citric acid as the acidic component of dialysate can enable a dose reduction of heparin and
increase the efficiency of hemodialysis. However, the amount of citrate (0.8 mmol/L) and
calcium (1.25-1.75 mmol/L) contained in this dialysate do not allow the target of iCa to be
reached in the ECC. In contrast, a citrate dialysate that contains no calcium would provide
enough calcium-free transfer to lower iCa below 0.45 mmol/L; however, a problem would be the
large amount of calcium loss during the session.
Pivotal studies show that, during dialysis sessions performed with calcium-free dialysate,
the rate of calcium reinjection required to compensate for calcium loss in the dialysate can
be easily deducted from the ionic dialysance (ID), which is an online measurement of
instantaneous small solute clearance, available from most dialysis monitors. ID has been also
used as a surrogate marker for dialysis dose in ICU patients receiving IHD. Thus, the use of
calcium-free citrate-containing dialysate with calcium reinjection according to ID could
provide enough citrate to prevent coagulation within the filter, and calcium restitution can
then be monitored by online ID without the need for systemic measurement of iCa. It may also
improve the hemodynamic tolerance of IHD by avoiding acetate in the dialysate.
The objective of the present study was to show the efficiency of this approach using RCA for
dialysis sessions (<4 hrs) of IHD in patients with moderate to high risk of bleeding, based
on the success rate of hemodialysis without clotting. Each patient included in this study
will receive two heparin-free dialysis sessions with heparin-grafted membrane (control group)
or RCA with calcium-free citrate-containing dialysate and calcium reinjection according to
the ionic dialysance (experimental group), alternatively. The order of anticoagulation will
be randomized.
