RCA for CRRT in Hyperlactatemia Patient With Increased Bleeding Risk

Bleeding Clinical Trial

Official title:

Regional Citrate Anticoagulation Versus No-anticoagulation for CRRT in Hyperlactatemia Patients With Increased Bleeding Risk: a Randomized, Control, Open-labeled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04315623
• Other study ID #: RCA-CRRT-Hyperlactatemia
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 30, 2020
• Est. completion date: March 3, 2022

Study information

• Verified date: March 2020
• Source: Fourth Military Medical University
• Contact: Ming Bai, MD
• Phone: +86029-84775197
• Email: mingbai1983[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 3, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Continuous Renal Replacement Therapy
• Hemorrhage
• Hyperlactatemia

Intervention

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

Locations

Country	Name	City	State
China	Xijing Hospital of Nephrology	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Filter failure	TMP (transmembrane pressure) = 300 mmHg, extracorporeal coagulation due to blood clots	72 hours
Secondary	Serum Total Ca2+/ion Ca2+ level	Serum Total Ca2+/ion Ca2+ level	2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Secondary	Serum AST level	AST	Every 24 hours up to 72 hours
Secondary	Serum total bilirubin level	Total bilirubin	Every 24 hours up to 72 hours
Secondary	Serum citrate concentration	Citrate concentration	2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Secondary	Serum lactate level	Serum lactate level	2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Secondary	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.	72 hours
Secondary	Hypocalcemia	Ionized Ca2+ < 1.0	72 hours
Secondary	Acidosis	Blood pH < 7.35	72 hours
Secondary	Alkalosis	Blood pH > 7.45	72 hours
Secondary	Bleeding	Bleeding episode during the CRRT	72 hours
Secondary	APTT	activated partial thromboplastin time	Every 24 hours up to 72 hours
Secondary	PT	Prothrombin time	Every 24 hours up to 72 hours
Secondary	INR	International normalized ratio	Every 24 hours up to 72 hours
Secondary	Mortality	In-hospital mortality	Up to 3 months