2.Application of regional citrate anticoagulation in patients at high risk of bleeding during intermittent hemodialysis: a prospective multicenter randomized controlled trial.
Xiaoyan TANG ; Dezheng CHEN ; Ling ZHANG ; Ping FU ; Yanxia CHEN ; Zhou XIAO ; Xiangcheng XIAO ; Weisheng PENG ; Li CHENG ; Yanmin ZHANG ; Hongbo LI ; Kehui LI ; Bizhen GOU ; Xin WU ; Qian YU ; Lijun JIAN ; Zaizhi ZHU ; Yu WEN ; Cheng LIU ; Hen XUE ; Hongyu ZHANG ; Xin HE ; Bin YAN ; Liping ZHONG ; Bin HUANG ; Mingying MAO
Journal of Zhejiang University. Science. B 2022;23(11):931-942
OBJECTIVES:
Safe and effective anticoagulation is essential for hemodialysis patients who are at high risk of bleeding. The purpose of this trial is to evaluate the effectiveness and safety of two-stage regional citrate anticoagulation (RCA) combined with sequential anticoagulation and standard calcium-containing dialysate in intermittent hemodialysis (IHD) treatment.
METHODS:
Patients at high risk of bleeding who underwent IHD from September 2019 to May 2021 were prospectively enrolled in 13 blood purification centers of nephrology departments, and were randomly divided into RCA group and saline flushing group. In the RCA group, 0.04 g/mL sodium citrate was infused from the start of the dialysis line during blood draining and at the venous expansion chamber. The sodium citrate was stopped after 3 h of dialysis, which was changed to sequential dialysis without anticoagulant. The hazard ratios for coagulation were according to baseline.
RESULTS:
A total of 159 patients and 208 sessions were enrolled, including RCA group (80 patients, 110 sessions) and saline flushing group (79 patients, 98 sessions). The incidence of severe coagulation events of extracorporeal circulation in the RCA group was significantly lower than that in the saline flushing group (3.64% vs. 20.41%, P<0.001). The survival time of the filter pipeline in the RCA group was significantly longer than that in the saline flushing group ((238.34±9.33) min vs. (221.73±34.10) min, P<0.001). The urea clearance index (Kt/V) in the RCA group was similar to that in the saline flushing group with no statistically significant difference (1.12±0.34 vs. 1.08±0.34, P=0.41).
CONCLUSIONS
Compared with saline flushing, the two-stage RCA combined with a sequential anticoagulation strategy significantly reduced extracorporeal circulation clotting events and prolonged the dialysis time without serious adverse events.
Humans
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Citric Acid/adverse effects*
;
Prospective Studies
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Sodium Citrate
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Hemorrhage/chemically induced*
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Citrates/adverse effects*
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Anticoagulants/adverse effects*
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Renal Dialysis/adverse effects*
3.Metabolic alkalosis induced by plasmapheresis in a patient with systemic lupus erythematosus.
Moon Young CHOI ; Joung Deuk LEE ; Seung Hun LEE ; In Seok PARK ; Je Young WOO ; Euy Jin CHOI ; Yoon Sik CHANG ; Byung Kee BANG
Journal of Korean Medical Science 1993;8(3):207-209
We report a patient with systemic lupus erythematosus (SLE), who had developed metabolic alkalosis during plasmapheresis. The metabolic alkalosis could be promptly corrected by reducing the amount of citrate load. The development of metabolic alkalosis can be explained by the citrate load during plasmapheresis. Careful monitoring of acid base status is mandatory in patients with limited renal function and the reduction of citrate load may be advisable in plasmapheresis.
Adolescent
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Alkalosis/*etiology
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Citrates
;
Citric Acid
;
Female
;
Humans
;
Lupus Erythematosus, Systemic/*metabolism/therapy
;
Plasmapheresis/*adverse effects/methods
4.Postmarketing Assessment of Sildenafil in Terms of Safety and Efficacy.
Korean Journal of Andrology 2004;22(3):101-108
PURPOSE: The main purpose of postmarketing surveillance of drugs is to better characterize the safety profile of drug therapy in routine clinical practice. Another goal is to confirm the effectiveness of the tested drugs in clinical practice. A postmarketing survey was undertaken to monitor the safety and efficacy of sildenafil citrate (SC) as a treatment for erectile dysfunction in Korean men. MATERIALS AND METHODS: This 6-week, observational, open-label, uncontrolled, longitudinal, prospective study was conducted by 50 general hospitals across Korea. Men aged > or =20 years with erectile dysfunction who, in their physicians' opinion, should be treated with SC were enrolled for this study. To evaluate efficacy, the global efficacy assessment questionnaire (GEAQ) was administered before, and 2~4 weeks and 4~6 weeks following the initiation of SC therapy. Information regarding adverse drug reaction (ADR)s was collected on case-report forms designed for each visit and analyzed by the scientific committee of the study. RESULTS: A total of 935 patients were enrolled, and 818 patients were assessable for safety. A total of 561 patients satisfied the requirements for efficacy analysis. Seventy-two patients (8.8%) experienced 99 ADRs over the 6 weeks. The most common ADRs were facial flushing (5.7%) and headache (2.0%). Eight patients discontinued the medication due to ADR. In response to the global efficacy assessment question, 91.4% of patients reported that SC improved their erectile function. Unlike the results of clinical trials, 67.2% of the population studied required 50 mg sildenafil to attain satisfactory erection. CONCLUSIONS: In this postmarketing surveillance study of Korean patients with erectile dysfunction treated in routine clinical practice, SC showed a satisfactory tolerability and efficacy profile that was consistent with that seen in randomized, controlled trials.
Citric Acid
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Drug Therapy
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Drug-Related Side Effects and Adverse Reactions
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Erectile Dysfunction
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Flushing
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Headache
;
Hospitals, General
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Humans
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Korea
;
Male
;
Prospective Studies
;
Sildenafil Citrate
5.Regional Anticoagulation with Citrate is Superior to Systemic Anticoagulation with Heparin in Critically Ill Patients Undergoing Continuous Venovenous Hemodiafiltration.
Joon Sung PARK ; Gheun Ho KIM ; Chong Myung KANG ; Chang Hwa LEE
The Korean Journal of Internal Medicine 2011;26(1):68-75
BACKGROUND/AIMS: Short hemofilter survival and anticoagulation-related life-threatening complications are major problems in systemic anticoagulation with heparin (SAH) for continuous renal replacement therapy (CRRT). The present study examined if regional anticoagulation with citrate (RAC) using commercially available solutions can overcome the associated problems of SAH to produce economical benefits. METHODS: Forty-six patients were assigned to receive SAH or RAC. We assessed the coagulation state, clinical outcomes, and adverse events. A Kaplan-Meier analysis was used to estimate hemofilter life span. The economical benefit related to the prolonged hemofilter survival was examined on the basis of the average daily cost. RESULTS: The mean age of patients was 66.5 +/- 13.8 years and the majority were male (60.9%). While elective discontinuation was most common cause of early CRRT interruption in the RAC group (34.3%, p < 0.01), hemofilter clotting was most prevalent in the SAH group (82.2%, p < 0.01). The patient metabolic and electrolyte control and survival rate were not different between the two groups. When compared with the RAC group, the anticoagulation-associated bleeding was a major complication in the SAH group (15.0% vs. 61.5%, p < 0.01). Regional anticoagulated hemofilters displayed a significantly longer survival time than systemic anticoagulated hemofilters (59.5 +/- 3.8 hr vs. 15.6 +/- 1.3 hr, p < 0.01). Accordingly, the mean daily continuous venovenous hemodiafiltration costs in the RAC and SAH groups were $575 +/- 268 and $1,209 +/- 517, respectively (p < 0.01). CONCLUSIONS: RAC prolonged hemofilter survival, displaying an economical benefit without severe adverse effects. The present study therefore demonstrates that RAC, using commercially available solutions, may be advantageous over SAH as a cost-effective treatment in CRRT.
Adult
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Aged
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Anticoagulants/*pharmacology
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Citric Acid/*pharmacology
;
Critical Illness
;
Female
;
Health Care Costs
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*Hemodiafiltration/adverse effects/economics/mortality
;
Heparin/*pharmacology
;
Humans
;
Kaplan-Meier Estimate
;
Male
;
Middle Aged
6.Regional citrate anticoagulation in critically ill patients during continuous blood purification.
Dehua GONG ; Daxi JI ; Bin XU ; Honglang XIE ; Yun LIU ; Leishi LI
Chinese Medical Journal 2003;116(3):360-363
OBJECTIVESTo evaluate the safety and define the contraindication of regional citrate anticoagulation treatment on various critically ill patients being treated by continuous blood purification, who also had bleeding tendencies.
METHODSForty critically ill patients being treated by continuous blood purification (CBP) were involved in this study. Due to their bleeding tendencies, regional citrate anticoagulation treatment was given to all of them. Those with hepatic function impairment (n = 10) were classified as Group A, those with hypoxemia were classified as Group B (n = 10), and the others as Group C (n = 20). Blood samples were collected before treatment, and at 4, 12, 24, 36, and 48 hour intervals during CBP. These samples then were used arterial blood gas analysis, whole blood activated clotting time (WBACT) pre- and post-filter, and serum ionized calcium examination.
RESULTSWBACT pre-filter showed little fluctuant through the 48 hr period of CBP, and WBACT post-filter showed obvious prolongation than that of the pre-filter (P < 0.05) at all time points. Metabolic acidosis was found in Group A patients before CBP, and improved during CBP. Normal acid-base conditions of patients were disturbed and deteriorated in Group B during CBP, but not in Group C. Serum ionized calcium was maintained at a normal range during CBP in Group A and C patients, but declined significantly in Group B patients (vs. pre-treatment, P < 0.05).
CONCLUSIONSRegional citrate anticoagulation can be safely used in conjunction with CBP treatment for patients with hepatic function impairment, but may induce acidosis and a decline in serum ionized calcium when used with hypoxemic patients.
Adult ; Aged ; Anticoagulants ; administration & dosage ; Calcium ; blood ; Citric Acid ; administration & dosage ; adverse effects ; Critical Illness ; Female ; Hemofiltration ; Humans ; Male ; Middle Aged
7.Role of local citrate anticoagulation in continuous blood purification to patients at high risk of bleeding in ICU.
Shangping ZHAO ; Hao OU ; Yue PENG ; Zuoliang LIU ; Mingshi YANG ; Xuefei XIAO
Journal of Central South University(Medical Sciences) 2016;41(12):1334-1339
To evaluate the safety and efficiency of citrate anticoagulant-based continuous blood purification in patients at high risk of bleeding.
Methods: One hundred and fifty-two patients at high risk of bleeding were divided into local citrate group (group A, n=68) and heparin group (group B, n=84). Clotting function, change of pH, ionized sodium, bicarbonate ion, ionized calcium, activated clotting time (ACT) and complications were monitored before and during treatment.
Results: Compared to the group A, the incidence of clotting in filter and chamber, the degree of bleeding or fresh bleeding were significantly reduced in the group B (P<0.05). ACT of post-filter at 4, 8 and 12 h during the treatment in the group A was significantly extended compared with that without treatment (P<0.05), while there was no significant change in group B (P>0.05). The pH value, the levels of ionized sodium, bicarbonate ion and ionized calcium during the treatment were maintained in normal range in both group A and group B.
Conclusion: Local citrate-based continuous blood purification can achieve effective anticoagulation and decrease the incidence of bleeding. It is an ideal choice for patients at high risk of bleeding.
Anticoagulants
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pharmacology
;
Bicarbonates
;
blood
;
Blood Coagulation
;
drug effects
;
Blood Coagulation Tests
;
Calcium
;
blood
;
Citrates
;
Citric Acid
;
therapeutic use
;
Female
;
Hemodiafiltration
;
adverse effects
;
methods
;
Hemofiltration
;
Hemorrhage
;
etiology
;
prevention & control
;
Heparin
;
therapeutic use
;
Humans
;
Intensive Care Units
;
Male
;
Reference Values
;
Renal Dialysis
;
Sodium
;
blood
;
Treatment Outcome