Compare Efficacy and Simplicity of Regional Citrate Anticoagulation With Fixed Dose Versus Adjusted Citrate Program

NCT02663960 | Completed Phase 4 DMC

• 1 other identifier: ZS-950
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Anticoagulation is required to prevent clotting in the extracorporeal circuit during continuous renal replacement therapy (CRRT). Regional citrate anticoagulation has many advantages regarding bleeding risk and filter survival. However, in clinical practice, its use worldwide has been limited by cumbersome protocols . In order to establish a simple scheme for universal application. In Aug 2015, the investigators have adopted a new protocol using a fixed citrate concentration in the filter of about 4 mmol/L (called fixed group for short) instead of conventional adjusted citrate doses according to postfilter ionized calcium levels of less than 0.4mmol/l (adjusted group), and speculated the abilities on efficacy and safety as well as convenience.

Conditions

Critical Illness; Kidney Replacement Disorder; Coagulation; Intravascular

Keywords

Regional citrate anticoagulation; Protocol; Filter lifespan

Outcome Measures

Primary Outcomes (1)

• the survival time of the first filter due to unexpected disconnection

  The interval (hours) of the installation and replacement of the first filter. The unexpected disconnection defined as filter clotting more than two grades or transmembranous pressure across the circuit exceeded \>300 mmHg. The filters were changed routinely after 72 hours of CVVH treatment, so maximum survival time of the filter was recorded as 72 hrs.

  the time period on CVVH, maximum 72 hour

Secondary Outcomes (5)

• the overall survival time of the first filter

  the time period on CVVH, maximum 72 hour

• the frequency of change in the infusion pump rate of calcium gluconate 10% Injection

  the time period on CVVH, maximum 72 hour

• the frequency of change in the infusion pump rate of Sodium Bicarbonate 5% Injection

  the time period on CVVH, maximum 72 hour

• the frequency of change in the infusion pump rate of Anticoagulant Citrate Dextrose Solution

  the time period on CVVH, maximum 72 hour

• incidences of severe metabolic disorders

  the time period on CVVH, maximum 72 hour

Study Arms (2)

fixed citrate doses protocol

EXPERIMENTAL

Fixed citrate doses protocol: Anticoagulant Citrate Dextrose Solution ( Na+ 224, citrate 113, bicarbonate 203mmol/l, Fresenius Kabi, Italy) was administered in the prefilter ahead of the blood pump, which was set to meet a circuit citrate concentration of 4 mmol/l (duration: the maximum time is 72 hrs).

Other: fixed citrate doses protocol

adjusted citrate doses protocol

ACTIVE COMPARATOR

Adjusted citrate doses protocol: Anticoagulant Citrate Dextrose Solution ( Na+ 224, citrate 113, bicarbonate 203mmol/l, Fresenius Kabi, Italy) was administered in the prefilter ahead of the blood pump, which the starting infusion rate be set 2.5 % of blood flow ( dosage range: 160-250ml/h) and then be adjusted to obtain postfilter ionized calcium levels of less than 0.40 mmol/l (duration: the maximum time is 72 hrs. )

Other: adjusted citrate doses protocol

Interventions

fixed citrate doses protocol OTHER

fixed doses of anticoagulant citrate dextrose solution to meet a circuit citrate concentration of 4 mmol/l.

Also known as: fixed citrate circuit concentration protocol

fixed citrate doses protocol

adjusted citrate doses protocol OTHER

the starting infusion rate of anticoagulant citrate dextrose solution be set 2.5 % of blood flow and then be adjusted to obtain postfilter ionized calcium levels of less than 0.40 mmol/l.

adjusted citrate doses protocol

Eligibility Criteria

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

You may qualify if:

• All patients older than 18 years of age who required CVVH were consecutively screened

You may not qualify if:

• Requiring extracorporeal membrane oxygenation (ECMO) at the time of hemofiltration, insufficient data available or missing and running time less than 6 hours

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

MICU of Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• Shi Y, Qin HY, Peng JM, Hu XY, Du B. Feasibility and efficacy of modified fixed citrate concentration protocol using only commercial preparations in critically ill patients: a prospective cohort study with a historical control group. BMC Anesthesiol. 2021 Mar 30;21(1):96. doi: 10.1186/s12871-021-01319-4.

  PMID: 33784963 DERIVED

MeSH Terms

Conditions

Critical Illness; Thrombosis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bin Du, Prof.

  Department of medical ICU,Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2016
• First Posted: January 26, 2016
• Study Start: August 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 16, 2020

Record last verified: 2016-08

Locations

CN (1)