NCT04062812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

January 12, 2024

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

August 6, 2019

Last Update Submit

January 10, 2024

Conditions

Acute Renal FailureDialysis; ComplicationsCitrate Poisoning

Keywords

sodium citratecalcaemiamagnesiumphosphorusionic calcium

Outcome Measures

Primary Outcomes (4)

  • Dialysis flow

    Speed at which the dialysis fluid pump is programmed in the circuit and measured in milliliters / hour

    6 hours

  • Blood flow

    Speed at which the blood pump is programmed in the dialysis circuit and measured in milliliters / min

    6 hours

  • Citrate dose

    Relationship that exists between the liquid we infuse (which contains 18mmol / L citrate) and the blood pump. It is measured in mmol citrate / liter of blood

    6 hours

  • Calcium dose

    Amount of calcium that is replenished to the patient when the dialyzed blood is returned. It is measured in%.

    6 hours

Secondary Outcomes (15)

  • Filter operating hours

    number of hours

  • Arterial pH

    6 hours

  • Arterial bicarbonate

    6 hours

  • Post-filter ionic calcium

    6 hours

  • Ionic Calcium Patien

    6 hours

  • +10 more secondary outcomes

Study Arms (2)

Diluted citrate

EXPERIMENTAL

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

Other: the same citrate dosification in both types

Concentrated citrate

ACTIVE COMPARATOR

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

Other: the same citrate dosification in both types

Interventions

the same citrate dosification in both typesOTHER

match concentrated and dilute citrate protocol

Concentrated citrateDiluted citrate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • parenteral nutrition
  • pregnancy
  • cardiac surgery
  • coronary patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Barcelona, 08041, Spain

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Quasi-experimental design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 20, 2019

Study Start

August 1, 2019

Primary Completion

October 1, 2021

Study Completion

December 20, 2021

Last Updated

January 12, 2024

Record last verified: 2023-02

Locations

ES(1)