New Protocol With Diluted Citrate in Continuous Techniques

NCT ID: NCT04062812

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-12-20

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.

Conditions

Acute Renal Failure; Dialysis; Complications; Citrate Poisoning

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Diluted citrate

Initial citrate dose 3.5 mmol/L Initial calcium programmed 100% ("compensation dose") only dialysis and ratio 1:10 (blood/dialysis) No fluids in the repositioning scale

Group Type: EXPERIMENTAL

the same citrate dosification in both types

Intervention Type: OTHER

match concentrated and dilute citrate protocol

Concentrated citrate

Initial citrate dose: 3.5 mmol/L Initial calcium dose: 1.9 mmol/L and 1:20 ratio (blood/dialysis) No convection programmed

Group Type: ACTIVE_COMPARATOR

the same citrate dosification in both types

Intervention Type: OTHER

match concentrated and dilute citrate protocol

Interventions

the same citrate dosification in both types

match concentrated and dilute citrate protocol

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Countries

Spain

Other Identifiers

IIBSP-CIT-2019-34

Identifier Type: -

Identifier Source: org_study_id