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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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20 August 2018 |
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Main ID: |
ISRCTN69952745 |
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Date of registration:
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08/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Using citrate as anticoagulation for haemodlalysis
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Scientific title:
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Simple citrate anticoagulation protocol for low flux haemodialysis |
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Date of first enrolment:
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01/08/2015 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN69952745 |
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Study type:
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Interventional |
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Study design:
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Prospective open-label cross-over study (Treatment)
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Phase:
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Terina
Seow |
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Address:
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Division of Renal Medicine, Department of General Medicine
Khoo Teck Puat Hospital
90 Yishun Central
768828
Singapore
Singapore |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Hospital in-patients scheduled for at least 2 heparin-free hemodialysis sessions between August 2015-Jul 2016 at Khoo Teck Puat Hospital, Singapore
2. Haemoglobin >7.0g/dL
3. Haemodynamically stable
4. Reasonably functioning vascular access
5. Chronic haemodialysis patients and acute kidney injury patients
Exclusion criteria: 1. Decompensated liver disease
2. Received blood products within last 24 hours/required blood products during the dialysis session
3. Haemostatic disorders or deranged clotting
4. Known allergy to citrate products
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Haemodialysis
Urological and Genital Diseases
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Intervention(s)
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Patients were allocated either to regional citrate anticoagulation or standard heparin free haemodialysis and subsequently cross over to the alternate method. The same cohort underwent both treatment arms (citrate and saline flushes) in consecutive haemodialysis sessions which would have been 48-72 hours apart. Citrate is 60-80% dialysed out immediately as it passes through the dialyser and the rest is metabolized by the body within minutes so no washout period is required. Blood tests were performed during and at the end of the citrate treatment sessions
Trisodium Citrate 13% or 500mM (Dirinco BV, Netherland) was infused at a fixed rate pre-filter (into the “heparin” line) according to blood flow (QB) as shown.
Trisodium Citrate 13% Infusion:
Blood flow Trisodium citrate 13%
150 ml/min 60ml/hour
200 ml/min 80ml/hour
250 ml/min 100ml/hour
Calcium Gluconate 10% (2.2 mmol Ca2+ in 10ml vial) was infused post filter (using a 3-way connector into the “venous” return line). Infusion rate was started at 70ml/hour. Calcium infusion rate is then adjusted to pre-filter iCa2+ level.
Calcium Gluconate 10% Infusion:
iCa2+ Level Calcium Gluconate Infusion
<0.65 mM Notify doctor. Terminate citrate infusion and change to heparin free
dialysis. Give 40 ml bolus over 30 mins
0.65-0.74 mM Give 20ml bolus over 30 mins and increase infusion by 20 ml/hr
0.75 – 0.9 mM Increase infusion by 20 ml/hr
0.91 – 1.2 mM Infuse at 70ml/hr
>1.2 mM Hold infusion for 30 mins and recheck
For the control arm, 100ml saline flushes were given per 30 minutes, extra flushes were allowed as per nurses’s discretion according to standard practice of monitoring for clots in the circuit.
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Primary Outcome(s)
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1. Thrombosis and circuit loss: at the end of the dialysis session, arterial and venous drip chambers and the filter were inspected by the nurse for visible signs of coagulation. A score of 1 (no clots), 2 (small clots), 3 (large clots) and 4 (complete clotting of circuit) was applied.
2. Anticoagulation achieved in citrate dialysis arm: post-filter iCa2+ (V) was tested at time 30, 60, 120 and 240 (just before ending) minutes.
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Secondary Outcome(s)
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Electrolytes and calcium levels for citrate dialysis arm: pre-filter iCa2+ levels (A) were measured at 0, 30, 60, 120 and 240 minutes. Electrolytes were sent to the lab at time 0 and 240 minutes.
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Source(s) of Monetary Support
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Alexandra Health National Medical Research Centre
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Ethics review
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Status:
Approval date:
Contact:
National Health Group Domain Specific Research Board, 02/04/2015, ref: 2014/01037
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/07/2016 |
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URL:
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