Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814341
Status:
RECRUITING
Last Update Posted:
2023-07-25
First Post:
2023-04-03
Brief Title:
Citrate Anticoagulation in Renal Replacement Therapy Impact of a High Post-filter Calcium Target on Efficacy
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
The Effect of Increasing Post-Filter Ionized Target on the Efficacy of Regional Citrate Anticoagulation During Continuous Renal Replacement Therapy in Intensive Care a Multicenter Randomized Controlled Non-Inferiority Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ca-CIBLE
Brief Summary:
Regional citrate anticoagulation RCA is the recommended method for anticoagulation in continuous renal replacement therapy CRRT However the optimal post-filter ionized calcium iCa target level remains unclear Currently it is titrated to a post-filter iCa target ranging from 025 to 035 mmolL which is derived from a few underpowered trials There are potential side effects associated with citrate administration which may be increased in patient with liver failure andor tissue dysoxia such as alkalemia acidemia hypernatremia hypocalcemia hypomagnesemia and citrate accumulation Consequently citrate anticoagulation is contraindicated in the most severe cases The challenge is to use the minimum necessary dose of citrate to ensure both effective anticoagulation of the circuit and limit citrate administration to reduce the risks of metabolic complications and accumulation This approach expands the indications for citrate standardizes practice and reduces financial costs Investigators hypothesized that increasing the post-filter iCa target in RCA can limit the dose of citrate thereby avoiding adverse effects safety without compromising the effectiveness of the treatment in preventing filter clotting The aim of this study is to evaluate the impact of an increased post-filter iCa target from 025-035 to 035-045 mmolL on the incidence of filter clotting for RCA-CRRT in critically ill patients Investigators are designing a multicenter randomized controlled non-inferiority study
Detailed Description:
RCA-CRRT will be ordered based on clinical indications and will be performed according to a standardized protocol available as online supplementary material in continuous veno-venous hemofiltration mode with the same system Prismaflex Gambro-Baxter Deerfield IL USA and a 09 m2 high-flux AN69 membrane Blood flow will be maintained between 120 and 180 mLmin according to the patients ideal body weight The prescribed dose of filtration will be 30 mLkgh to achieve a delivered dose of 20-25 mLkgh following KDIGO guidelines A citrated replacement solution Regiocit Gambro-Baxter containing 180 mmolL of citrate will be delivered continuously to the blood before the filter of the extracorporeal circuit The rate of infusion of predilution replacement flow will be coupled to the blood flow aiming for a stable citrate concentration in the extracorporeal circuit The initial citrate dose will be 30 mmolL of blood and then citrate flow rate will be adjusted to the post-filter iCa target according to the protocol Post-filter iCa will be measured on ABL90 FLEX PLUS Radiometer Medical Copenhagen Denmark blood gas analyzer 15 minutes after any change in dose and then every 6 hours Calcium chloride will be administered to the patient through a central line to maintain systemic-iCa within 100-130 mmolL Fluid removal rates will be left to the discretion of the attending physician in order to achieve optimal fluid balance Additionally metabolic monitoring will be carried out by a blood ionogram every 12 hours The quantitative parameters will be presented as median and interquartile range IQR and comparisons will be made using either Students t-test or the Mann-Whitney U test depending on whether the assumptions of the t-test are met or not Categorical data will be reported as the number and percentage and will be compared using Fishers exact or chi-square test as appropriate The incidence of filter clotting will be expressed in absolute values n and percentage Comparison between groups will be performed using Pearsons Chi-square test The analysis of the primary endpoint will be conducted on a per-protocol basis as a first intention the most conservative approach in a non-inferiority study and on an intention-to-treat basis Filter lifespan until clotting curves according to the post-filter iCa2 target will be plotted using the Kaplan-Meier method and compared using the log-rank test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-003678-22 | OTHER | ANSM | None |