RCA for CRRT in Hyperlactatemia Patient With Increased Bleeding Risk

NCT04315623 | Unknown

• 1 other identifier: RCA-CRRT-Hyperlactatemia
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Continuous Renal Replacement Therapy; Hyperlactatemia; Bleeding

Outcome Measures

Primary Outcomes (1)

• Filter failure

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

  72 hours

Secondary Outcomes (14)

• Serum Total Ca2+/ion Ca2+ level

  2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours

• Serum AST level

  Every 24 hours up to 72 hours

• Serum total bilirubin level

  Every 24 hours up to 72 hours

• Serum citrate concentration

  2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours

• Serum lactate level

  2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours

Study Arms (2)

Reginal citrate anticoagulation

EXPERIMENTAL

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.

Procedure: Regional citrate anticoagulation CRRT

No-anticoagulation

ACTIVE COMPARATOR

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

Procedure: No-anticoagulation CRRT

Interventions

Regional citrate anticoagulation CRRT 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.

Reginal citrate anticoagulation

No-anticoagulation CRRT PROCEDURE

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

No-anticoagulation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital of Nephrology

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Hyperlactatemia; Hemorrhage

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Shiren Sun, MD

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Bai, MD

CONTACT

+86029-84775197; mingbai1983@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 19, 2020
• Study Start: March 30, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 3, 2022
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)