Clinical trial NCT02860130: Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
Official title: Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Regional Citrate Anticoagulation (RCA)
Continuous Renal Replacement Therapy (CRRT)
Acute Kidney Injury
Keywords: Regional Citrate Anticoagulation (RCA)
Continuous Renal Replacement Therapy (CRRT)
Acute Kidney Injury
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2016-08-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to determine if an investigational new drug solution called Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous renal replacement therapy (CRRT). Patients who receive CRRT treatment with Prismocitrate 18 as the anticoagulant will be compared to patients who receive CRRT treatment with no anticoagulation.


Eligibility criteria: Inclusion Criteria:

1. Patient must be receiving medical care in an intensive care unit (ICU) (e.g., medical ICU, surgical ICU, cardiothoracic ICU, Trauma ICU, Mixed ICU, other).
2. Adult patients with AKI or other serious conditions who require treatment with CRRT.
3. Patients are expected to remain in the ICU and on CRRT for at least 72 hours after randomization.
4. Patients already receiving standard-of-care CRRT must be randomized within 24 hours of initiation of their standard-of-care CRRT.

Exclusion Criteria:

1. Patients requiring systemic anticoagulation with antithrombotic agents for reasons other than CRRT. The exception is patients receiving subcutaneous heparin for deep vein thrombosis prophylaxis according to institutional practice or patients on aspirin may be enrolled.
2. Patients in whom citrate anticoagulation is contraindicated such as patients with a known allergy to citrate or who have experienced adverse events associated with citrate products including patients with a prior history of citrate toxicity or patients with uncorrected severe hypocalcemia (whether in the context of current citrate administration or due to the underlying disease state).
3. Patients who are not candidates for CRRT.
4. Patients who are receiving extracorporeal membrane oxygenation (ECMO) therapy.
5. Patients with severe coagulopathy \[i.e., platelets \< 30,000/mm3, international normalized ratio (INR) \> 2, partial thromboplastin time (PTT) \> 50 seconds\] including severe thrombocytopenia (platelets \< 30,000/mm3), HIT (heparin induced thrombocytopenia), ITP (idiopathic thrombocytopenia purpura), and TTP (thrombotic thrombocytopenia purpura) should not be enrolled in the trial.
6. Patients with fulminant acute liver failure or acute on chronic liver failure as documented by a Child-Pugh Liver Failure Score \> 10.
7. Patients with refractory shock associated persistent, worsening with lactic acidosis (lactate \> 4 mmol/L). However, patients with improving subsequent serum lactate levels may be enrolled.
8. Patients unlikely to survive at least 72 hours.
9. Female patients who are pregnant, lactating, or planning to become pregnant during the study period.
10. Patients who are currently participating in another interventional clinical study.
11. Patients with a medical condition that may interfere with the study objectives.

Primary outcomes:
measure: Time to Occurrence of Selected Prismaflex® System Alarms/Conditions
timeFrame: Up to 120 hours post CRRT treatment initiation
Secondary outcomes:
measure: Change From Baseline in Patient Ionized Calcium (iCa) by Hour
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Extracorporeal Circuit Ionized Calcium by Hour
timeFrame: Up to 120 hours post CRRT treatment initiation
measure: Delivery of Prescribed CRRT Dose by Day
timeFrame: Up to 120 hours post CRRT treatment initiation
measure: Number of Investigator Site Facilities That Passed Prismocitrate 18 Training Assessment
timeFrame: Prior to study use of Prismocitrate 18
measure: Change From Baseline in Serum Bicarbonate by Hour
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Change From Baseline in pH by Hour
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Change From Baseline in Base Excess by Hour
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Change From Baseline in Blood Total Calcium Concentration by Hour
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Change From Baseline in Serum Sodium by Hour
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Change From Baseline in Serum Anion Gap by Hour
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Change From Baseline in Serum Magnesium by Hour
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Change From Baseline in Serum Phosphate by Hour
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Change From Baseline in Serum Potassium by Hour
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Change From Baseline in Serum Chloride by Hour
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Number of Participants With Bleeding Events
timeFrame: Up to 120 hours post CRRT treatment initiation
measure: Number of Participants by Number of Blood Transfusions
timeFrame: Up to 120 hours post CRRT treatment initiation
measure: Number of Participants Reporting Any Baxter Device/Product Related Adverse Events (Serious and Non-Serious)
timeFrame: Up to 30 days post study CRRT treatment completion
measure: Change From Baseline in Blood Pressure at Last Visit
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Change From Baseline in Respiratory Rate at Last Visit
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Change From Baseline in Temperature at Last Visit
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Change From Baseline in Pulse at Last Visit
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Change From Baseline in Total Calcium/iCa Ratio by Hour
timeFrame: Baseline and up to 120 hours post CRRT treatment initiation
measure: Number of Bleeding Events by Location
timeFrame: Up to 120 hours post CRRT treatment initiation
measure: Duration of Bleeding Events
timeFrame: Up to 120 hours post CRRT treatment initiation
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess (Harvard)
state: Massachusetts
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
References:
citation: Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.