RCA for CRRT in Hyperlactatemia Patient With Increased Bleeding Risk

NCT ID: NCT04315623

Last Updated: 2020-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2022-03-03

Brief Summary

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The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk.

Detailed Description

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For continuous renal replacement therapy (CRRT) patients with shock and muscle hypoperfusion, which characterised by tissue hypoxia and hyperlactatemia, the Kidney Disease Improving Global Outcomes (KIDIGO) guideline recommended no use of regional citrate anticoagulation (RCA) considering the potential increased citrate accumulation (CA) risk. In the condition of increased bleeding, no-anticoagulation was recommended for these patients. However, CRRT processed without anticoagulation was proved to be associated with shorter filter lifespan. Therefore, the purpose of this single center, randomized, control, open-labeled study is to evaluate the safety and efficacy of RCA versus no-anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk.

Conditions

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Continuous Renal Replacement Therapy Hyperlactatemia Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reginal citrate anticoagulation

Patients accepted regional citrate anticoagulation for CRRT. Blood flow 120-220 ml/h. Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L. Adjusting the infusion rate of sodium citrate and blood flow according to pre- and post-filtration ionCa2+. Adjusting the infusion rate of calcium gluconate according to the serum ionCa2+ level.

Group Type EXPERIMENTAL

Regional citrate anticoagulation CRRT

Intervention Type PROCEDURE

Regional citrate anticoagulation Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.

No-anticoagulation

Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution.

Group Type ACTIVE_COMPARATOR

No-anticoagulation CRRT

Intervention Type PROCEDURE

Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution.

Interventions

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Regional citrate anticoagulation CRRT

Regional citrate anticoagulation Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.

Intervention Type PROCEDURE

No-anticoagulation CRRT

Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age≥16 years
* Hyperlactatemia (Lactic acid or serum lactate level \> 2 mmol/L)
* Required CRRT
* Increased bleeding risk: PLT \< 40 x 109, aPTT \> 60 s, INR \> 1.5, bleeding or active bleeding within 7 days, recent trauma or surgery (especially head trauma and neurosurgery), recent stroke, intracranial venous malformation or aneurysm, retinal hemorrhage, uncontrolled hypertension, and epidural catheter implantation.

Exclusion Criteria

* Drugs (biguanide, linezolid, cyanide, etc.) and congenital metabolic disorders (glucose-6 phosphatase and 1,6 phosphofructosase deficiency) and mitochondrial damage caused hyperlactatemia.
* Receiving systemic anticoagulant treatment (heparin/lmol/warfarin/aspirin, etc.) within 24 hours.
* Critical patients with lactic acid ≥15mmol\\L (with a mortality of 100%) were excluded
* Patients with APTT \> 100S were excluded (retrospective data suggested that this type of patients received CRRT treatment should last for more than 24 hours)
* Patients who are pregnant or during lactation
* Severe liver failure: child-pugh score \>10 (chronic severe liver failure), MELD score \> 30 (acute severe liver failure), total bilirubin \>51 mol/L
* Patients with internal fistula were treated with CRRT
* Unable to cooperate with treatment due to mental problems (such as depression and mental illness)
* CRRT with arteriovenous fistula, or the prescribed treatment time \< 12 hours
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Shiren sun

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shiren Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Locations

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Xijing Hospital of Nephrology

Xi'an, Shaanxi, China

Site Status

Countries

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China

Central Contacts

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Ming Bai, MD

Role: CONTACT

+86029-84775197

Other Identifiers

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RCA-CRRT-Hyperlactatemia

Identifier Type: -

Identifier Source: org_study_id

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