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RCA for CRRT in Hyperlactatemia Patient With Increased Bleeding Risk

Primary Purpose

Continuous Renal Replacement Therapy, Hyperlactatemia, Bleeding

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Regional citrate anticoagulation CRRT
No-anticoagulation CRRT
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Continuous Renal Replacement Therapy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xijing Hospital of Nephrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reginal citrate anticoagulation

No-anticoagulation

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Filter failure
TMP (transmembrane pressure) ≥ 300 mmHg, extracorporeal coagulation due to blood clots

Secondary Outcome Measures

Serum Total Ca2+/ion Ca2+ level
Serum Total Ca2+/ion Ca2+ level
Serum AST level
AST
Serum total bilirubin level
Total bilirubin
Serum citrate concentration
Citrate concentration
Serum lactate level
Serum lactate level
citrate accumulation
Metabolic acidosis with an increased anion gap, decreasing ionized calcium, elevated total calcium and the calcium ratio (totCa/ionCa) > 2.5 were considered as citrate accumulation.
Hypocalcemia
Ionized Ca2+ < 1.0
Acidosis
Blood pH < 7.35
Alkalosis
Blood pH > 7.45
Bleeding
Bleeding episode during the CRRT
APTT
activated partial thromboplastin time
PT
Prothrombin time
INR
International normalized ratio
Mortality
In-hospital mortality

Full Information

First Posted
February 29, 2020
Last Updated
March 18, 2020
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT04315623
Brief Title
RCA for CRRT in Hyperlactatemia Patient With Increased Bleeding Risk
Official Title
Regional Citrate Anticoagulation Versus No-anticoagulation for CRRT in Hyperlactatemia Patients With Increased Bleeding Risk: a Randomized, Control, Open-labeled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2020 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 3, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Continuous Renal Replacement Therapy, Hyperlactatemia, Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reginal citrate anticoagulation
Arm Type
Experimental
Arm Description
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.
Arm Title
No-anticoagulation
Arm Type
Active Comparator
Arm Description
Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution.
Intervention Type
Procedure
Intervention Name(s)
Regional citrate anticoagulation CRRT
Intervention Description
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
Intervention Name(s)
No-anticoagulation CRRT
Intervention Description
Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution.
Primary Outcome Measure Information:
Title
Filter failure
Description
TMP (transmembrane pressure) ≥ 300 mmHg, extracorporeal coagulation due to blood clots
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Serum Total Ca2+/ion Ca2+ level
Description
Serum Total Ca2+/ion Ca2+ level
Time Frame
2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Title
Serum AST level
Description
AST
Time Frame
Every 24 hours up to 72 hours
Title
Serum total bilirubin level
Description
Total bilirubin
Time Frame
Every 24 hours up to 72 hours
Title
Serum citrate concentration
Description
Citrate concentration
Time Frame
2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Title
Serum lactate level
Description
Serum lactate level
Time Frame
2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Title
citrate accumulation
Description
Metabolic acidosis with an increased anion gap, decreasing ionized calcium, elevated total calcium and the calcium ratio (totCa/ionCa) > 2.5 were considered as citrate accumulation.
Time Frame
72 hours
Title
Hypocalcemia
Description
Ionized Ca2+ < 1.0
Time Frame
72 hours
Title
Acidosis
Description
Blood pH < 7.35
Time Frame
72 hours
Title
Alkalosis
Description
Blood pH > 7.45
Time Frame
72 hours
Title
Bleeding
Description
Bleeding episode during the CRRT
Time Frame
72 hours
Title
APTT
Description
activated partial thromboplastin time
Time Frame
Every 24 hours up to 72 hours
Title
PT
Description
Prothrombin time
Time Frame
Every 24 hours up to 72 hours
Title
INR
Description
International normalized ratio
Time Frame
Every 24 hours up to 72 hours
Title
Mortality
Description
In-hospital mortality
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Bai, MD
Phone
+86029-84775197
Email
mingbai1983@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiren Sun, MD
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital of Nephrology
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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RCA for CRRT in Hyperlactatemia Patient With Increased Bleeding Risk

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