Patients Undergoing Continuous Venovenous Hemodiafiltration: Effects of Increased Blood Flow

NCT05796661 | Unknown DMC

• 1 other identifier: CRRT-QbTrial
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Acute Kidney Injure (AKI) is a syndrome with high incidence and prevalence in Intensive Care Units (ICU). It is estimated that 50% of the in the sector present AKI at some point and 10 to 15% require renal replacement therapy (RRT). Although studies do not show the superiority of continuous methods, the most severely ill patients are directed to this type of RRT. A disadvantage of continuous therapies is the need for anticoagulation. Critically ill patients have a pro-clotting state (inflammation) and several risk factors for bleeding (coagulopathies, postoperative, large vessel puncture). On the one hand, ineffective anticoagulation compromises the efficiency of the procedure, shortens the life of the extracorporeal system, consumes resources and increases blood loss due to unexpected and early filter clotting. There is no consensus on what would be the optimal blood flow (Qb) in continuous dialysis, especially when regional citrate anticoagulation (RCA) is used. Theoretically, a higher flow rate would prevent stasis in the system and decrease the risk of filter clotting. Studies show conflicting results. Increasing Qb from 150 to 250 mL/min showed that circuit life and the chance of coagulation were similar. On the other hand, blood flow is important for maintaining the filtration fraction (FF), the ratio of ultrafiltrate flow to plasma flow. Ideally, the FF should be kept below 25% to avoid hemoconcentration and coagulation of the filter. Therefore, the higher the convection rate, the higher the blood flow should be to keep the FF in the optimal range. Since the anticoagulation capacity of citrate is dependent on its concentration, around 4 mmol/L of blood, by increasing the blood flow, the citrate infusion is proportionally increased. Theoretically, the higher citrate load offered should be metabolized and, in theory, could cause its overload with the occurrence of metabolic alkalosis and hypernatremia. This situation occurs when its maximum metabolizing capacity is not reached and there is an excess of citrate infusion relative to the buffering requirement. Thus, we intend to evaluate filter useful life, metabolic control, electrolyte profile and acid-base balance in ICU patients undergoing continuous venovenous hemodiafiltration (CVVHDF), regional citrate anticoagulation during blood flow augmentation.

Conditions

Acute Kidney Injury

Keywords

Continuous renal replacement therapy; Blood flow; Filtration fraction

Outcome Measures

Primary Outcomes (1)

• Analyze filter/system useful life

  Evaluate the duration of the continuous hemodiafiltration filter according to changes in blood flow

  72 hours per filter

Secondary Outcomes (8)

• Examine the system pressures

  72 hours per filter

• Assess filtration fraction variation

  72 hours per filter

• Electrolytic control - Potassium

  72 hours per filter (dosage every 12 hours according to protocol)

• Electrolytic control - Sodium

  72 hours per filter (dosage every 12 hours according to protocol)

• Acid-base balance - blood pH

  72 hours per filter (venous blood gas analysis every 12 hours)

Study Arms (2)

Qb150

EXPERIMENTAL

This group will be exposed to continuous venovenous therapy with a blood flow of 150ml/min; already standardized by the institution; for a maximum time of 72 hours or interrupted sooner if the system clots or the filter loses patency. Both groups will have a "wash out" of 6 hours before crossing the arms of the work.

Other: Effects of increased blood flow during regional anticoagulation with 4% trisodium citrate in patients undergoing continuous venovenous hemodiafiltration

Qb 250

ACTIVE COMPARATOR

This group will be exposed to continuous venovenous therapy with a blood flow of 250ml/min; experimental group to evaluate increased blood flow and filter durability; for a maximum time of 72 hours or interrupted sooner if the system clots or the filter loses patency. Both groups will have a "wash out" of 6 hours before crossing the arms of the work.

Other: Effects of increased blood flow during regional anticoagulation with 4% trisodium citrate in patients undergoing continuous venovenous hemodiafiltration

Interventions

Effects of increased blood flow during regional anticoagulation with 4% trisodium citrate in patients undergoing continuous venovenous hemodiafiltration OTHER

Patients will be exposed to continuous venovenous renal therapy with distinct blood flows in 2 periods, to be defined by draw. The control group will have a flow of 150ml/min and the intervention group 250ml/min. Therapy is intended for a period of 72 hours (maximum defined by the manufacturer); with a 6-hour "washout" and, after that, the arm is changed to be exposed to the other blood flow.

Qb 250; Qb150

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years.
• Weight ≥ 50 Kg.
• Agreeing to participate in the study (TCLE duly elucidated and signed by the patient or family member/guardian).
• Admitted to the hospital ICU.
• Acute Kidney Injury in need of RRT and indication (according to the evaluation of the assistant nephrologist) of continuous therapy.

You may not qualify if:

• Age \< 18 years.
• Weight \< 50 Kg.
• Refusal to participate in the study (absence of informed consent).
• Patient with chronic kidney disease on dialysis

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelite Albert Einstein

São Paulo, Brazil

Location

Related Publications (14)

• Kellum JA, Romagnani P, Ashuntantang G, Ronco C, Zarbock A, Anders HJ. Acute kidney injury. Nat Rev Dis Primers. 2021 Jul 15;7(1):52. doi: 10.1038/s41572-021-00284-z.

  PMID: 34267223 BACKGROUND

• Fuhrman DY, Kellum JA. Acute Kidney Injury in the Intensive Care Unit: Advances in the Identification, Classification, and Treatment of a Multifactorial Syndrome. Crit Care Clin. 2021 Apr;37(2):xiii-xv. doi: 10.1016/j.ccc.2021.01.001. Epub 2021 Feb 13. No abstract available.

  PMID: 33752867 BACKGROUND

• Bellomo R, Baldwin I, Ronco C, Kellum JA. ICU-Based Renal Replacement Therapy. Crit Care Med. 2021 Mar 1;49(3):406-418. doi: 10.1097/CCM.0000000000004831. No abstract available.

  PMID: 33555775 BACKGROUND

• Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

  PMID: 22890468 BACKGROUND

• Khadzhynov D, Schelter C, Lieker I, Mika A, Staeck O, Neumayer HH, Peters H, Slowinski T. Incidence and outcome of metabolic disarrangements consistent with citrate accumulation in critically ill patients undergoing continuous venovenous hemodialysis with regional citrate anticoagulation. J Crit Care. 2014 Apr;29(2):265-71. doi: 10.1016/j.jcrc.2013.10.015. Epub 2013 Nov 11.

  PMID: 24360392 BACKGROUND

• Gattas DJ, Rajbhandari D, Bradford C, Buhr H, Lo S, Bellomo R. A Randomized Controlled Trial of Regional Citrate Versus Regional Heparin Anticoagulation for Continuous Renal Replacement Therapy in Critically Ill Adults. Crit Care Med. 2015 Aug;43(8):1622-9. doi: 10.1097/CCM.0000000000001004.

  PMID: 25853591 BACKGROUND

• Stucker F, Ponte B, Tataw J, Martin PY, Wozniak H, Pugin J, Saudan P. Efficacy and safety of citrate-based anticoagulation compared to heparin in patients with acute kidney injury requiring continuous renal replacement therapy: a randomized controlled trial. Crit Care. 2015 Mar 18;19(1):91. doi: 10.1186/s13054-015-0822-z.

  PMID: 25881975 BACKGROUND

• Meersch M, Kullmar M, Wempe C, Kindgen-Milles D, Kluge S, Slowinski T, Marx G, Gerss J, Zarbock A; SepNet Critical Care Trials Group. Regional citrate versus systemic heparin anticoagulation for continuous renal replacement therapy in critically ill patients with acute kidney injury (RICH) trial: study protocol for a multicentre, randomised controlled trial. BMJ Open. 2019 Jan 21;9(1):e024411. doi: 10.1136/bmjopen-2018-024411.

  PMID: 30670518 BACKGROUND

• Zarbock A, Kullmar M, Kindgen-Milles D, Wempe C, Gerss J, Brandenburger T, Dimski T, Tyczynski B, Jahn M, Mulling N, Mehrlander M, Rosenberger P, Marx G, Simon TP, Jaschinski U, Deetjen P, Putensen C, Schewe JC, Kluge S, Jarczak D, Slowinski T, Bodenstein M, Meybohm P, Wirtz S, Moerer O, Kortgen A, Simon P, Bagshaw SM, Kellum JA, Meersch M; RICH Investigators and the Sepnet Trial Group. Effect of Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation During Continuous Kidney Replacement Therapy on Dialysis Filter Life Span and Mortality Among Critically Ill Patients With Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2020 Oct 27;324(16):1629-1639. doi: 10.1001/jama.2020.18618.

  PMID: 33095849 BACKGROUND

• Kramer L, Bauer E, Joukhadar C, Strobl W, Gendo A, Madl C, Gangl A. Citrate pharmacokinetics and metabolism in cirrhotic and noncirrhotic critically ill patients. Crit Care Med. 2003 Oct;31(10):2450-5. doi: 10.1097/01.CCM.0000084871.76568.E6.

  PMID: 14530750 BACKGROUND

• Bauer E, Derfler K, Joukhadar C, Druml W. Citrate kinetics in patients receiving long-term hemodialysis therapy. Am J Kidney Dis. 2005 Nov;46(5):903-7. doi: 10.1053/j.ajkd.2005.07.041.

  PMID: 16253731 BACKGROUND

• Yu W, Zhuang F, Ma S, Fan Q, Zhu M, Ding F. Optimized Calcium Supplementation Approach for Regional Citrate Anticoagulation. Nephron. 2019;141(2):119-127. doi: 10.1159/000494693. Epub 2018 Nov 16.

  PMID: 30448847 BACKGROUND

• Schneider AG, Journois D, Rimmele T. Complications of regional citrate anticoagulation: accumulation or overload? Crit Care. 2017 Nov 19;21(1):281. doi: 10.1186/s13054-017-1880-1.

  PMID: 29151020 BACKGROUND

• AYRES, M., AYRES Jr, M., AYRES, D. L., SANTOS, A. A. S. Bioestat 5.3 aplicações estatísticas nas áreas das ciências biológicas e médicas. Belém: IDSM, 2007.364p.

  BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

trisodium citrate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Lucas T Avila Neto

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, crossover, single-center study, with inclusion of patients over a period of 11 months, between January 9, 2023 and November 30, 2023. We aim to include 27 patients. Randomized by raffle, which will be carried out manually in blocks divided into 3 envelopes numbered from 01 to 03, and within them will contain 9 papers, also numbered from 1 to 27 with the definition of control group and experimental group. Following the order from 01 to 03, the envelopes will have: envelope 1: 9 samples (5 for control group and 4 for experimental group); envelope 2: 9 samples (4 for control group and 5 for experimental group); envelope 3: 9 samples (5 for control group and 4 for experimental group). Groups: Qb150 (control group) (blood flow 150 mL/min), Qb250 (experimental group) (blood flow 250 mL/min). Time for each treatment: 72 hours. Crossover: after 72 hours. Treatment pause (wash-out): 4 (minimum) to 6 (maximum) hours.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 3, 2023
• Study Start: January 9, 2023
• Primary Completion: January 9, 2023
• Study Completion: September 30, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)