Impact of CVVHD With Adsorption Capacity Membranes in Septic Acute Kidney Injury

NCT01790620 | Completed DMC

• 2 other identifiers: SIRAKI 00-2012PR 148/12
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

Septic patients with acute kidney injury (SA-AKI) requiring continuous renal replacement therapies (CRRT) present high mortality due to systemic inflammatory response, cytokine liberation, and finally multiorgan dysfunction. Cytokine plasmatic elimination with continuous venovenous hemofiltration (CVVH) presents frequent complications, known as "dialytrauma", and a high resource cost both technical and human. The study primary end-point is to demonstrate a longer filter life with the use of continuous venovenous hemodialysis (CVVHD) respect to CVVH, both modalities employing the same adsorption capacity membrane. As secondary end-points investigators will try to demonstrate less dialytrauma events of CVVHD respect to CVVH. In order to achieve these objectives investigators have designed a proof of concept exploratory trial that will include those patients whom present SA-AKI meeting CRRT initiation criteria. During the first 72 hours investigators will measure plasmatic elimination capacity of main cytokines, and other clinical and prognostic relevant molecules. Investigators will also measure hemodynamic, respiratory, and metabolic parameters. Adverse effects related to CRRT ("dialytrauma") will also be registrated. Finally, investigators will analyze 90 days survival. Demonstration of a minor complication rate (longer filter patency with less dialytrauma events) with a similar immunomodulating capacity and with its consequent lower cost, should settle the based evidence principles that recommend the use of CVVHD asociated to an adsorption capacity membrane in patients with SA-AKI whom need CRRT.

Conditions

Sepsis; Septic Shock; Acute Kidney Injury

Keywords

Sepsis; Septic shock; Acute renal failure; Acute kidney injury; Continuous renal replacement therapies CRRT

Outcome Measures

Primary Outcomes (1)

• Technical CRRT efficiency

  Number of times set was changed.

  72 hours

Secondary Outcomes (6)

• Safety technical superiority.

  72 hours

• Survival at 90 days after randomization

  90 days.

• Immunomodulating capacity

  72 hours

• Renal depuration capacity.

  72 hours.

• Hemodynamics and respiratory variations.

  72 hours.

Study Arms (2)

CVVHD-ST150

EXPERIMENTAL

Patients with sepsis whom present AKI meeting CRRT initiation criteria will be started on CVVHD with PrismafleX eXeed™ II (Hospal) using an ST150SET copolymer of acrylonitrile and sodium methylsulfonate (AN 69) with polyethylenimine treated surface. Anticoagulation of the ST150 set with unfractioned heparin will only be initiated if there´s no clinical contraindication. ST150 set will be changed when clotted and every 24 hours during the first 72 hours of CVVHD. No citrate anticoagulation will be used.

Other: CVVHD

CVVH-ST150

ACTIVE COMPARATOR

Patients with sepsis whom present AKI meeting CRRT initiation criteria will be started on CVVH with PrismafleX eXeed™ II (Hospal) using an ST150SET copolymer of acrylonitrile and sodium methylsulfonate (AN 69) with polyethylenimine treated surface. Anticoagulation of the ST150 set with unfractioned heparin will only be initiated if there´s no clinical contraindication. ST150 set will be changed when clotted and every 24 hours during the first 72 hours of CVVH. No citrate anticoagulation will be used.

Other: CVVH

Interventions

CVVHD OTHER

CVVHD will be used during 72 hours with a prescribed dose of 30 ml/Kg/h Prismasol® 4 as dialysate fluid. Blood flow of 200-250 ml/min, to achieve 12 - 15 L/h will be prescribed. Isovolemic CRRT will be encouraged during this 72 hours if volume overload status is not present. After 72 hours, CVVHD will be continued and dialysate dose (ml/kg/h) will be adjusted to achieve creatinine levels between 80-120 umol/L until patient recovers urine output and / or tolerates intermittent hemodialysis.

Also known as: Continuous venovenous hemodialysis

CVVHD-ST150

CVVH OTHER

CVVH will be used during 72 hours with a prescribed dose of 30 ml/Kg/h Prismasol® 4 as reposition fluid. Blood flow of 200-250 ml/min, to achieve 12 - 15 L/h will be prescribed adjusting the adequate percentage of prefilter reinfusion to maintain a theorical filtration fraction between 18-22%. Isovolemic CRRT will be encouraged if volume overload status is not present. After 72 hours, CVVH will be continued and filtration dose (ml/kg/h) will be adjusted to achieve creatinine levels between 80-120 umol/L until patient recovers urine output and / or tolerates intermittent hemodialysis.

Also known as: Continuous venovenous hemofiltration

CVVH-ST150

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Severe Sepsis or Septic shock (SCCM definitions)
• Correct therapeutic initial management of septic process (SSC guidelines)
• Clinical diagnosis of Acute Kidney Injury (ADQI definitions)
• Acute Kidney Injury meeting CRRT initiation criteria (ADQI guidelines)
• Written informed consent from patient or legal surrogates

You may not qualify if:

• End Stage Renal Disease(ESRD)
• Received previous CRRT or hemodialysis in the last three months
• Coexisting illness with a high probability of death
• Immunosuppression

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Hospital de Sant Pau: collaborator

Study Sites (2)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (19)

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• Hofmann CL, Fissell WH. Middle-molecule clearance at 20 and 35 ml/kg/h in continuous venovenous hemodiafiltration. Blood Purif. 2010;29(3):259-63. doi: 10.1159/000266483. Epub 2009 Dec 17.

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• Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.

  PMID: 34519356 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic; Acute Kidney Injury

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Joan Sabater Riera, MD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

• Xosé L. Pérez Fernández, MD

  Hospital Universitari de Bellvitge

  STUDY DIRECTOR

• Antoni Betbesé Roig, MD

  Hospital de Sant Pau

  STUDY DIRECTOR

• Jorge Ordoñez Llanos, MD PhD

  Hospital de Sant Pau

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 13, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 29, 2019

Record last verified: 2019-07

Locations

ES (2)