Continuous Renal Replacement TherapyNCT04315623
RCA for CRRT in Hyperlactatemia Patient With Increased Bleeding Risk
A study testing Regional citrate anticoagulation CRRT and No-anticoagulation CRRT in people with Continuous Renal Replacement Therapy and Hyperlactatemia, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Continuous Renal Replacement Therapy, Hyperlactatemia, Bleeding
- What is being tested?
- Regional citrate anticoagulation CRRT and No-anticoagulation CRRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2020to 3 Mar 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age≥16 years
- Hyperlactatemia (Lactic acid or serum lactate level > 2 mmol/L)
- Required CRRT
- Increased bleeding risk: PLT < 40 x 109, aPTT > 60 s, INR > 1.5, bleeding or active bleeding within 7 days, recent trauma or surgery (especially head trauma and neurosurgery), recent stroke, intracranial venous malformation or aneurysm, retinal hemorrhage, uncontrolled hypertension, and epidural catheter implantation.
Who cannot join
- Drugs (biguanide, linezolid, cyanide, etc.) and congenital metabolic disorders (glucose-6 phosphatase and 1,6 phosphofructosase deficiency) and mitochondrial damage caused hyperlactatemia.
- Receiving systemic anticoagulant treatment (heparin/lmol/warfarin/aspirin, etc.) within 24 hours.
- Critical patients with lactic acid ≥15mmol\L (with a mortality of 100%) were excluded
- Patients with APTT > 100S were excluded (retrospective data suggested that this type of patients received CRRT treatment should last for more than 24 hours)
- Patients who are pregnant or during lactation
- Severe liver failure: child-pugh score >10 (chronic severe liver failure), MELD score > 30 (acute severe liver failure), total bilirubin >51 mol/L
Show all 9Show fewer
- Patients with internal fistula were treated with CRRT
- Unable to cooperate with treatment due to mental problems (such as depression and mental illness)
- CRRT with arteriovenous fistula, or the prescribed treatment time < 12 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regional Citrate Anticoagulation Versus No-anticoagulation for CRRT in Hyperlactatemia Patients With Increased Bleeding Risk: a Randomized, Control, Open-labeled Clinical Trial
The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk.
Read the detailed description
For continuous renal replacement therapy (CRRT) patients with shock and muscle hypoperfusion, which characterised by tissue hypoxia and hyperlactatemia, the Kidney Disease Improving Global Outcomes (KIDIGO) guideline recommended no use of regional citrate anticoagulation (RCA) considering the potential increased citrate accumulation (CA) risk. In the condition of increased bleeding, no-anticoagulation was recommended for these patients. However, CRRT processed without anticoagulation was proved to be associated with shorter filter lifespan. Therefore, the purpose of this single center, randomized, control, open-labeled study is to evaluate the safety and efficacy of RCA versus no-anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk.
- Being tested
- Regional citrate anticoagulation CRRT, No-anticoagulation CRRT
- Medical subject headings
- Hyperlactatemia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional citrate anticoagulation CRRTProcedure or surgery
Regional citrate anticoagulation Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.
No-anticoagulation CRRTProcedure or surgery
Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution.
| Study group | Role | What they receive |
|---|---|---|
| Reginal citrate anticoagulation | Experimental | Patients accepted regional citrate anticoagulation for CRRT. Blood flow 120-220 ml/h. Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L. Adjusting the infusion rate of sodium citrate and blood flow according to pre- and post-filtration ionCa2+. Adjusting the infusion rate of calcium gluconate according to the serum ionCa2+ level. Receives: Procedure: Regional citrate anticoagulation CRRT |
| No-anticoagulation | Active comparator | Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution. Receives: Procedure: No-anticoagulation CRRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Filter failure
TMP (transmembrane pressure) ≥ 300 mmHg, extracorporeal coagulation due to blood clots
Measured: 72 hours
Secondary outcomes (14)
Serum Total Ca2+/ion Ca2+ level
Serum Total Ca2+/ion Ca2+ level
Measured: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Serum AST level
AST
Measured: Every 24 hours up to 72 hours
Serum total bilirubin level
Total bilirubin
Measured: Every 24 hours up to 72 hours
Serum citrate concentration
Citrate concentration
Measured: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Serum lactate level
Serum lactate level
Measured: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
citrate accumulation
Metabolic acidosis with an increased anion gap, decreasing ionized calcium, elevated total calcium and the calcium ratio (totCa/ionCa) > 2.5 were considered as citrate accumulation.
Measured: 72 hours
Hypocalcemia
Ionized Ca2+ < 1.0
Measured: 72 hours
Acidosis
Blood pH < 7.35
Measured: 72 hours
Alkalosis
Blood pH > 7.45
Measured: 72 hours
Bleeding
Bleeding episode during the CRRT
Measured: 72 hours
APTT
activated partial thromboplastin time
Measured: Every 24 hours up to 72 hours
PT
Prothrombin time
Measured: Every 24 hours up to 72 hours
INR
International normalized ratio
Measured: Every 24 hours up to 72 hours
Mortality
In-hospital mortality
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start30 Mar 2020 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion3 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Renal Replacement TherapyStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiren sun, Air Force Military Medical University, China
- Investigators
- Shiren Sun, MD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315623
- Sponsor's protocol ID
- RCA-CRRT-Hyperlactatemia
- Status last verified
- Mar 2020
- First submitted
- 29 Feb 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Citrate Anticoagulation Versus No-anticoagulation for CRRT in Hyperlactatemia Patients With Increased Bleeding Risk: a Randomized, Control, Open-labeled Clinical Trial
- ClinicalTrials.gov ID
- NCT04315623
- Acronym / sponsor ID
- RCA-CRRT-Hyperlactatemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 30 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 3 Mar 2022 (estimated)
- First posted
- 19 Mar 2020 (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.
The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk.
Detailed description
For continuous renal replacement therapy (CRRT) patients with shock and muscle hypoperfusion, which characterised by tissue hypoxia and hyperlactatemia, the Kidney Disease Improving Global Outcomes (KIDIGO) guideline recommended no use of regional citrate anticoagulation (RCA) considering the potential increased citrate accumulation (CA) risk. In the condition of increased bleeding, no-anticoagulation was recommended for these patients. However, CRRT processed without anticoagulation was proved to be associated with shorter filter lifespan. Therefore, the purpose of this single center, randomized, control, open-labeled study is to evaluate the safety and efficacy of RCA versus no-anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reginal citrate anticoagulation | Experimental | Procedure: Regional citrate anticoagulation CRRTPatients accepted regional citrate anticoagulation for CRRT. Blood flow 120-220 ml/h. Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L. Adjusting the infusion rate of sodium citrate and blood flow according to pre- and post-filtration ionCa2+. Adjusting the infusion rate of calcium gluconate according to the serum ionCa2+ level. |
| No-anticoagulation | Active comparator | Procedure: No-anticoagulation CRRTPatients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥16 years
- Hyperlactatemia (Lactic acid or serum lactate level > 2 mmol/L)
- Required CRRT
- Increased bleeding risk: PLT < 40 x 109, aPTT > 60 s, INR > 1.5, bleeding or active bleeding within 7 days, recent trauma or surgery (especially head trauma and neurosurgery), recent stroke, intracranial venous malformation or aneurysm, retinal hemorrhage, uncontrolled hypertension, and epidural catheter implantation.
Key exclusion criteria (9 listed)
- Drugs (biguanide, linezolid, cyanide, etc.) and congenital metabolic disorders (glucose-6 phosphatase and 1,6 phosphofructosase deficiency) and mitochondrial damage caused hyperlactatemia.
- Receiving systemic anticoagulant treatment (heparin/lmol/warfarin/aspirin, etc.) within 24 hours.
- Critical patients with lactic acid ≥15mmol\L (with a mortality of 100%) were excluded
- Patients with APTT > 100S were excluded (retrospective data suggested that this type of patients received CRRT treatment should last for more than 24 hours)
- Patients who are pregnant or during lactation
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 anticoagulation CRRTRegional citrate anticoagulation Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L. | Procedure or surgery | Reginal citrate anticoagulation |
| No-anticoagulation CRRTPatients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution. | Procedure or surgery | No-anticoagulation |
Primary outcome
Filter failure
Time frame: 72 hours
TMP (transmembrane pressure) ≥ 300 mmHg, extracorporeal coagulation due to blood clots
14 secondary outcomes
Serum Total Ca2+/ion Ca2+ level
Time frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Serum AST level
Time frame: Every 24 hours up to 72 hours
Serum total bilirubin level
Time frame: Every 24 hours up to 72 hours
Serum citrate concentration
Time frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Serum lactate level
Time frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
citrate accumulation
Time frame: 72 hours
Hypocalcemia
Time frame: 72 hours
Acidosis
Time frame: 72 hours
Alkalosis
Time frame: 72 hours
Bleeding
Time frame: 72 hours
APTT
Time frame: Every 24 hours up to 72 hours
PT
Time frame: Every 24 hours up to 72 hours
INR
Time frame: Every 24 hours up to 72 hours
Mortality
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Continuous Renal Replacement Therapy
Not yet recruitingObservational study
Magnesium Kinetics During Citrate-Anticoagulated CRRT
Continuous Renal Replacement Therapy (CRRT), Magnesium
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
Recruiting
LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)
Acute Kidney Injury, Dialysis; Complications
Recruiting
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
Acute Kidney Injury
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.
Shiren Sun, MD principal investigator
Xijing Hospital
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 CRRT and No-anticoagulation CRRT in people with Continuous Renal Replacement Therapy and Hyperlactatemia, run by Air Force Military Medical University, China at 1 site in China.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Mar 2020. 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Bai, MD (+86029-84775197, mingbai1983@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Filter failure (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2020.