Clinical trial NCT04062812: New Protocol With Diluted Citrate in Continuous Techniques
Official title: Comparison of Diluted vs Concentrated Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy: A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Renal Failure
Dialysis; Complications
Citrate Poisoning
Keywords: sodium citrate
calcaemia
magnesium
phosphorus
ionic calcium
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Quasi-experimental design
Primary purpose: TREATMENT

Brief summary: The investigators designed a monitoring and control table of a citrate treatment on a specific monitor. This is the Baxter "Prismaflex" monitor, with 8.2 software version. Dialysis bath liquids marketed by Baxter: Biphozyl are used. Citrate liquid (1:18) Regiocit is used.

The dialysis treatment monitor (CVVHD) is programmed, with a blood / citrate pumps at a rate of 1:10 (1 ml / min of blood: 10 ml / h of dialysis fluid) The starting dose of citrate will be 3.5 mmol / l and the calcium compensation will be 100% Working hypothesis: The patient undergoing citrate anticoagulation according to the designed algorithm will respond with ion stability and pH during the treatment, in addition to achieving an effective cleaning process.

Detailed description: Study design: quasi-experimental design. two groups:

1. Usual protocol with Multifiltrate monitor and citrate (136 mmol/l)
2. Intervention group. New protocol with Prismaflex monitor and citrate (18 mmol/l)

Study population Inclusión/exclusion criteria:

Adult patients (regardless of their underlying pathology), who develop acute renal failure, admitted to the ICU of St Pau Hospital with the Intensive Medicine medical team, who require citrate anticoagulation in continuous dialysis therapy and are treated with Baxter "Prismaflex" monitor.

Patients who meet the criteria described above will be followed up in this study.

Expected sample size:

It is estimated that with 24/12 (group1/2) patients will be enough to achieve our goal

Methodology. Information sources:

The start of the treatment with Baxter citrate will be given according to the patient's need and subject to a basic medical decision. From here the research team will enter. The investigation team will never influence the medical decision.

Since such a treatment is started, the main investigator will assign a number to the dialysis circuit and will be followed, every six hours, for the most important variables. The rest of the variables will be collected at least once a day and according to the patient's situation.

Eligibility criteria: Inclusion Criteria:

* Adult patients (regardless of their underlying pathology), who develop acute renal failure, admitted to the ICU of St Pau with the medical team of Intensive Medicine, who require anticoagulation with citrate in continuous dialysis therapy and are treated with the Baxter monitor.

Exclusion Criteria:

* parenteral nutrition
* pregnancy
* cardiac surgery
* coronary patients

Primary outcomes:
measure: Dialysis flow
timeFrame: 6 hours
measure: Blood flow
timeFrame: 6 hours
measure: Citrate dose
timeFrame: 6 hours
measure: Calcium dose
timeFrame: 6 hours
Secondary outcomes:
measure: Filter operating hours
timeFrame: number of hours
measure: Arterial pH
timeFrame: 6 hours
measure: Arterial bicarbonate
timeFrame: 6 hours
measure: Post-filter ionic calcium
timeFrame: 6 hours
measure: Ionic Calcium Patien
timeFrame: 6 hours
measure: Total calcium
timeFrame: 6 hours
measure: Total Ca / Ionic Ca Ratio
timeFrame: 24 hours
measure: Match
timeFrame: 24 hours
measure: Magnesium
timeFrame: 24 hours
measure: Sodium
timeFrame: 24 hours
measure: Potassium
timeFrame: 24 hours
measure: Urea
timeFrame: 24 hours
measure: Creatinine
timeFrame: 24 hours
measure: INR
timeFrame: 24 hours
measure: Lactate
timeFrame: 24 hours
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
Study officials:
References: