An interventional study of Regional citrate anticoagulation CRRT and No-anticoagulation CRRT in Continuous Renal Replacement Therapy, Hyperlactatemia and Bleeding, sponsored by Air Force Military Medical University, China. Status unknown at 1 site in China. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by Air Force Military Medical University, China · Not applicable, Interventional, and Treatment
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.
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.
50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.
This study's planned enrollment of 80 is above the median of 38 across 32 interventional studies indexed under Hyperlactatemia.
Browse Hyperlactatemia studies →Air Force Military Medical University, China is the lead sponsor of 178 studies on the registry; 37 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Regional citrate anticoagulation CRRT
Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution.
Procedure: No-anticoagulation CRRT
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.
Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution.
Filter failure
TMP (transmembrane pressure) ≥ 300 mmHg, extracorporeal coagulation due to blood clots
Time frame: 72 hours
Serum Total Ca2+/ion Ca2+ level
Serum Total Ca2+/ion Ca2+ level
Time frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Serum AST level
AST
Time frame: Every 24 hours up to 72 hours
Serum total bilirubin level
Total bilirubin
Time frame: Every 24 hours up to 72 hours
Serum citrate concentration
Citrate concentration
Time frame: 2, 6, 12, 20, 28, 36, 44, 52, 60, and 72 hours
Serum lactate level
Serum lactate level
Time frame: 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.
Time frame: 72 hours
Hypocalcemia
Ionized Ca2+ \< 1.0
Time frame: 72 hours
Acidosis
Blood pH \< 7.35
Time frame: 72 hours
Alkalosis
Blood pH \> 7.45
Time frame: 72 hours
Bleeding
Bleeding episode during the CRRT
Time frame: 72 hours
APTT
activated partial thromboplastin time
Time frame: Every 24 hours up to 72 hours
PT
Prothrombin time
Time frame: Every 24 hours up to 72 hours
INR
International normalized ratio
Time frame: Every 24 hours up to 72 hours
Mortality
In-hospital mortality
Time frame: Up to 3 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2020; primary completion for Mar 2022, 23 months later.
Of 17 interventional studies with no phase under Hyperlactatemia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's planned 23 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Air Force Military Medical University, China →