Regional Citrate AnticoagulationNCT04792424
No Monitoring of Post-filter Ionized Calcium in Regional Citrate Anticoagulation
A study testing Regional citrate anticoagulation, Vasopressor and Antibiotic in people with Regional Citrate Anticoagulation and Ionized Calcium, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Do no monitor of post-circuit ionized calcium affact the filter life time of continueous renal replacement therapy with regional citrate anticoagulation circuit? A randomized control trial Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Regional Citrate Anticoagulation, Ionized Calcium, Continuous Renal Replacement Therapy
- What is being tested?
- Regional citrate anticoagulation, Vasopressor and Antibiotic
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2021to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age older than 18 years old and admission in an ICU
- Indication for CRRT
- regional citrate anticoagulation
Who cannot join
- Acute liver failure defined as AST or ALT > 5X UNL or TB/DB > 5X UNL or evidence of cirrhosis
- Severe persistent lactic acidosis (lactate persist > 8 mg/dL consecutively within 6 hours)
- Receiving heparin anticoagulation
- Severe alkalosis (pH>7.55) or acidosis (pH<7.1)
- History of renal allograft
- Known pregnancy
- Patient is moribund with expected death within 24 hr
- Deficiency of ionzed calcium (Cation < 0.8 mmol/L)
Trial locations and contacts
1 site in 1 country.
About this study
Do no monitor of post-circuit ionized calcium affact the filter life time of continueous renal replacement therapy with regional citrate anticoagulation circuit? A randomized control trial
Read the detailed description
Regional citrate anticoagulation is the gold standard of anticoagulation in patient receiving CRRT. In RCA circuit, there was a monitoring of pre-filter (systemic) ionized calcium and post-filter (circuit) ionized calcium. Pre-filter ionized calcium was monitored for observe the adverse effect of citrate such as hypocalcemia, citrate intoxication. However, post-filter ionized calcium was monitored for adjustment the citrate dose. We find many problem with frequently monitoring of post-ionized calcium such as confusion from markedly abnormal result, how to adjustment the citrate dose ,and increase workload for nurses. We hypothesis that if we can monitoring of post-filter ionized calcium?
- Being tested
- Regional citrate anticoagulation, Vasopressor, Antibiotic, Dialysis with continuous renal replacement therapy
- Keywords
- Regional citrate anticoagulation, Ionized calcium, Continuous Renal Replacement Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional citrate anticoagulationOther
Starting RCA 4 mmol/L (adjust the rate by BFR)
VasopressorDrug
Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine
AntibioticDrug
Antibacterial agents deemed appropriate by physicians in the ICU
Dialysis with continuous renal replacement therapyDevice
Prismaflex
| Study group | Role | What they receive |
|---|---|---|
| No monitoring of post filter ionized calcium | Experimental | Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation.
Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate.
Citrate dose start at 4 mmol/L and no adjustment of citrate dose. Post-filter ionized calcium result will blind for physician.
Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour. Receives: Other: Regional citrate anticoagulation; Drug: Vasopressor; Drug: Antibiotic; Device: Dialysis with continuous renal replacement therapy |
| Monitoring of post filter ionized calcium | Placebo comparator | Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation.
Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate.
Citrate dose start at 4 mmol/L with adjustment of citrate dose to acheive post-filter ionized calcium at 0.25-0.35 mmol/L.
Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour. Receives: Other: Regional citrate anticoagulation; Drug: Vasopressor; Drug: Antibiotic; Device: Dialysis with continuous renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Filter lifetime in hours
How long with filter with RCA
Measured: 72 hours
Secondary outcomes (6)
Adverse event
adverse event of RCA
Measured: 72 hours
Circuit downtime in hours
Circuit downtime during CRRT with RCA
Measured: 72 hours
Cost per treatment in Baht
Cost of CRRT include laboratory in Baht
Measured: 72 hour
Citrate accumulation
Number of total calcium to ionized calcium ratio > 2.5
Measured: 72 hours
Efficacy of CRRT
Seiving coefficient of urea and difference of prescribed dose of CRRT
Measured: 72 hours
Citrate dose
Average citrate dose
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Apr 2021
- Primary completion30 May 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regional Citrate AnticoagulationStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Srisawat ,M.D., Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792424
- Sponsor's protocol ID
- IRB.35/64
- Status last verified
- Nov 2022
- First submitted
- 3 Mar 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thanapongsatorn P, Sinjira T, Kaewdoungtien P, Kusirisin P, Kulvichit W, Sirivongrangson P, Peerapornratana S, Lumlertgul N, Srisawat N. Standard versus no post-filter ionized calcium monitoring in regional citrate anticoagulation for continuous renal replacement therapy (NPC trial). Clin Kidney J. 2023 Mar 31;16(9):1469-1479. doi: 10.1093/ckj/sfad069. eCollection 2023 Sep.
PubMed 37664560
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Monitoring of Post-filter Ionized Calcium in Regional Citrate Anticoagulation
- ClinicalTrials.gov ID
- NCT04792424
- Acronym / sponsor ID
- IRB.35/64
- Keywords
- Regional citrate anticoagulation, Ionized calcium, Continuous Renal Replacement Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Do no monitor of post-circuit ionized calcium affact the filter life time of continueous renal replacement therapy with regional citrate anticoagulation circuit? A randomized control trial
Detailed description
Regional citrate anticoagulation is the gold standard of anticoagulation in patient receiving CRRT. In RCA circuit, there was a monitoring of pre-filter (systemic) ionized calcium and post-filter (circuit) ionized calcium. Pre-filter ionized calcium was monitored for observe the adverse effect of citrate such as hypocalcemia, citrate intoxication. However, post-filter ionized calcium was monitored for adjustment the citrate dose. We find many problem with frequently monitoring of post-ionized calcium such as confusion from markedly abnormal result, how to adjustment the citrate dose ,and increase workload for nurses. We hypothesis that if we can monitoring of post-filter ionized calcium?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No monitoring of post filter ionized calcium | Experimental | Other: Regional citrate anticoagulation, Drug: Vasopressor, Drug: Antibiotic, Device: Dialysis with continuous renal replacement therapyStarting dialysis with continuous renal replacement therapy with regional citrate anticoagulation. Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate. Citrate dose start at 4 mmol/L and no adjustment of citrate dose. Post-filter ionized calcium result will blind for physician. Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour. |
| Monitoring of post filter ionized calcium | Placebo comparator | Other: Regional citrate anticoagulation, Drug: Vasopressor, Drug: Antibiotic, Device: Dialysis with continuous renal replacement therapyStarting dialysis with continuous renal replacement therapy with regional citrate anticoagulation. Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate. Citrate dose start at 4 mmol/L with adjustment of citrate dose to acheive post-filter ionized calcium at 0.25-0.35 mmol/L. Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age older than 18 years old and admission in an ICU
- Indication for CRRT
- regional citrate anticoagulation
Key exclusion criteria (8 listed)
- Acute liver failure defined as AST or ALT > 5X UNL or TB/DB > 5X UNL or evidence of cirrhosis
- Severe persistent lactic acidosis (lactate persist > 8 mg/dL consecutively within 6 hours)
- Receiving heparin anticoagulation
- Severe alkalosis (pH>7.55) or acidosis (pH<7.1)
- History of renal allograft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional citrate anticoagulationStarting RCA 4 mmol/L (adjust the rate by BFR) | Other | Monitoring of post filter ionized calcium, No monitoring of post filter ionized calcium |
| VasopressorVasopressors such as Norepinephrine, dopamine, milrinone, dobutamine | Drug | Monitoring of post filter ionized calcium, No monitoring of post filter ionized calcium |
| AntibioticAntibacterial agents deemed appropriate by physicians in the ICU | Drug | Monitoring of post filter ionized calcium, No monitoring of post filter ionized calcium |
| Dialysis with continuous renal replacement therapyPrismaflex | Device | Monitoring of post filter ionized calcium, No monitoring of post filter ionized calcium |
Primary outcome
Filter lifetime in hours
Time frame: 72 hours
How long with filter with RCA
6 secondary outcomes
Adverse event
Time frame: 72 hours
Circuit downtime in hours
Time frame: 72 hours
Cost per treatment in Baht
Time frame: 72 hour
Citrate accumulation
Time frame: 72 hours
Efficacy of CRRT
Time frame: 72 hours
Citrate dose
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 37664560Thanapongsatorn P, Sinjira T, Kaewdoungtien P, Kusirisin P, Kulvichit W, Sirivongrangson P, Peerapornratana S, Lumlertgul N, Srisawat N. Standard versus no post-filter ionized calcium monitoring in regional citrate anticoagulation for continuous renal replacement therapy (NPC trial). Clin Kidney J. 2023 Mar 31;16(9):1469-1479. doi: 10.1093/ckj/sfad069. eCollection 2023 Sep.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional citrate anticoagulation, Vasopressor and Antibiotic in people with Regional Citrate Anticoagulation and Ionized Calcium, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Filter lifetime in hours (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04792424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.