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
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.
Design: This study was conducted as a single-centre, cohort study. All patients older than 18
years of age who required veno-venous hemofiltration (CVVH) were consecutively screened
forward (prospective) or backward (retrospective) from August, 2015 and until the expected
sample size was reached.
Study protocol: Before and after implementation of a new protocol, apart from the flow rate
of any supplementation (Anticoagulant-citrate-dextrose solution, 5% sodium bicarbonate
injection and 10% calcium gluconate injection), CVVH was performed using same standards,
including devices (Aquarius or Diapact® CRRT), venous catheter (a double lumen 12-F catheter,
Arrow International Inc., USA), haemofilter (DIACAP Acute L, 2.0 m2, B. Braun Melsungen AG,
Germany), commercial replacement fluids (Na+113, Cl-118, Mg++0.797, Ca++1.60, glucose
10.6mmo/l and zero bicarbonate; Qing-shan-li-kang pharmaceutical Co.,Ltd. Cheng-du, China)
and Anticoagulant-citrate-dextrose solution-A (ACD-A) (Na+ 224, citrate 113, bicarbonate
203mmol/l, Fresenius Kabi, Italy) as well as monitoring algorithm. The first sample of
postfilter and systemic ionized calcium was done two hours after initiation of CVVH and every
six to eight hours during the first 24 hours. Afterwards, these measurements were done
according to clinical needs for maintaining normal ionized calcium levels and blood pH value.
The group of fixed citrate concentration: ACD-A was administered in the prefilter ahead of
the blood pump and the infusion rate was fixed and set to meet a circuit citrate
concentration of 4 mmol/l. Calcium Gluconate 10% Injection was infused through the return
line of the circuit and the substitution flow was initiated with 0.8 mmol calcium per liter
total effluent flow and then be adjusted to obtain systemic ionized calcium levels between
0.90 and 1.2 mmol/l. Sodium bicarbonate 5% injection was infused through the return line of
the circuit and the substitution flow was initiated with 3.3% of replacement fluid flow and
then be adjusted to obtain blood pH value in the normal range (7.35 to 7.45)
The group of adjusted citrate doses:ACD-A was administered in the prefilter ahead of the
blood pump and the starting infusion rate was 2.5 % of blood flow and then be adjusted to
obtain postfilter ionized calcium levels of less than 0.40 mmol/l. Calcium Gluconate 10%
Injection was infused through the return line of the circuit and the substitution flow was
initiated with 7.3% of ACD-A flow, and then be adjusted to obtain systemic ionized calcium
levels between 0.90 and 1.2 mmol/l. Sodium bicarbonate 5% injection was infused through the
return line of the circuit and the starting infusion rate was 4% of replacement fluid
flow,and then be adjusted to obtain blood pH value in the normal range (7.35 to 7.45)
Statistical analyses: groups were compared by using Fisher's exact test, Student's t test or
Mann-Whitney rank-sum test as appropriate. Circuit lifetime was evaluated with Kaplan-Meier
survival analysis and survival curves distribution was compared with the Log Rank test.
Univariate and multivariate analysis were used to identify factors associated with mean
filter lifetime in all group patients.
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