Critical Illness Clinical Trial
Official title:
Is Regional Citrate Anticoagulation With Fixed Citrate Blood Concentration More Effective and Easy-to-handle Than Adjusted-dose Protocol in Adult Critically Ill Patients? A Cohort Study
NCT number | NCT02663960 |
Other study ID # | ZS-950 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | August 2015 |
Est. completion date | May 2016 |
Verified date | August 2016 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients older than 18 years of age who required CVVH were consecutively screened Exclusion Criteria: - Requiring extracorporeal membrane oxygenation (ECMO) at the time of hemofiltration, insufficient data available or missing and running time less than 6 hours |
Country | Name | City | State |
---|---|---|---|
China | MICU of Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | the overall survival time of the first filter | The interval (hours) of the installation and replacement of the first filter. The survival time derived from analysis of CVVH stopping for any cause. The reasons for CVVH stopping included unexpected disconnection (defined as filter clotting more than two grades or transmembranous pressure across the circuit exceeded >300 mmHg) and expected disconnection (such as scheduled, catheter malfunction, death or discharge, metabolic complications).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 | the frequency of change in the infusion pump rate of calcium gluconate 10% Injection | recorded the change frequency (times per patient per hour ) in calcium gluconate infusion pump during the treatment period. Data were collected from records of the daily prescriptions. | the time period on CVVH, maximum 72 hour | |
Secondary | the frequency of change in the infusion pump rate of Sodium Bicarbonate 5% Injection | recorded the change frequency (times per patient per hour) in bicarbonate infusion pump during the treatment period. Data were collected from records of the daily prescriptions. | the time period on CVVH, maximum 72 hour | |
Secondary | the frequency of change in the infusion pump rate of Anticoagulant Citrate Dextrose Solution | recorded the change frequency (times per patient per hour ) in citrate infusion pump during the treatment period. Data were collected from records of the daily prescriptions. | the time period on CVVH, maximum 72 hour | |
Secondary | incidences of severe metabolic disorders | defined as metabolic alkalosis with blood's pH value >7.5, metabolic acidosis with blood's pH value < 7.25, hypocalcemia with ionized calcium < 0.7 mmol/L, hypercalcemia with total serum calcium = 2.75mmol/L, hypernatremia with Na+ = 150mmol/L), bleeding disorders (defined as the decline of hemoglobin 10g/l within 12 hours) and suspected citrate accumulation was identified as a total calcium/ionic calcium index = 2.5 | the time period on CVVH, maximum 72 hour |
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