Multicenter clinical trial results with the lifesite® hemodialysis access system

Steve J. Schwab, Mark A. Weiss, Fred Rushton, John P. Ross, Jerry Jackson, Toros Kapoian, James Yegge, Melvin Rosenblatt, Woody J. Reese, Ramesh Soundararajan, Jack Work, Jamie Lynn Ross, Brian Stainken, Alexander Pedan, John A. Moran

Research output: Contribution to journalArticle

63 Citations (Scopus)

Abstract

Background. The LifeSite® Hemodialysis Access System is a subcutaneous access device designed to maximize blood flow while minimizing access-related complications. The purpose of this study was to compare the efficacy and safety of the LifeSite System to a similar but transcutaneous access device, the Tesio-Cath® Hemodialysis Catheter. Methods. The study was conducted in two phases. A multicenter randomized prospective design was utilized for the first phase (Phase 1) where thirty-four patients were enrolled in the Tesio-Cath group and 36 patients into the LifeSite group where 0.2% sodium oxychlorosene was used as an antimicrobial solution for the LifeSite. A nonrandomized, but otherwise identical, second phase of the study followed where a 70% isopropyl alcohol solution was utilized as the antimicrobial solution for 34 additional LifeSite patients (Phase 2). Results. Device function was evaluated in Phase 1 of the trial. Actual blood flow (determined by ultrasound dilution) was greater in the LifeSite versus the Tesio-Cath group (358.7 vs. 331.8 mL/min, P < 0.001 for machine-indicated blood flow of 400 mL/min). Infection comparisons were performed for all three groups encompassing Phase 1 and 2 of the trial; Tesio-Catheter, LifeSite System with oxychlorosene, and LifeSite System with 70% isopropyl alcohol. Device-related infections were defined as systemic bacteremia without another obvious site of origin and exit site infections requiring systemic antibiotics or device removal. This revealed infection rates per 1000 device use days of 1.3 for the LifeSite alcohol group, 3.3 for the Tesio-Cath group, and 3.4 per for the LifeSite oxychlorosene group. There was no statistically significant difference in device related infection rates between the Tesio-Cath and the LifeSite oxychlorosene groups. There were significant differences in infection rate between LifeSite alcohol group and the other two groups (P < 0.05). Device thrombosis was defined by the need for instillation of thrombolytic agents to maintain blood flow >300 mL/min. There was no difference in the need for thrombolytic infusions between the LifeSite oxychlorosene group and the Tesio-Cath group (P = 0.1496); however, the LifeSite alcohol group required significantly fewer thrombolytic infusions than the Tesio-Cath group (P = 0.0295) to maintain adequate blood flow. Device survival at 6 months after stratification by diabetic status and adjusting for age was significantly better in the LifeSite alcohol group (89.9%) than in the LifeSite oxychlorosene group (64.8%, P = 0.0286) and in the Tesio-Cath (69.1%, P = 0.0292) group. Conclusions. The LifeSite Hemodialysis Access System, when used with 70% isopropyl alcohol as an antimicrobial solution, provides superior performance with a lower infection rate and better device survival than a standard cuffed tunneled hemodialysis catheter.

Original languageEnglish (US)
Pages (from-to)1026-1033
Number of pages8
JournalKidney International
Volume62
Issue number3
DOIs
StatePublished - 2002
Externally publishedYes

Fingerprint

Multicenter Studies
Renal Dialysis
Clinical Trials
Equipment and Supplies
2-Propanol
Catheters
Alcohols
Survival
Safety
Infection
oxychlorosene

Keywords

  • Cuffed tunneled hemodialysis catheter
  • Dialysis catheter
  • Hemodialysis
  • Subcutaneous access device
  • Transcutaneous access device
  • Vascular access

ASJC Scopus subject areas

  • Medicine(all)
  • Nephrology

Cite this

Schwab, S. J., Weiss, M. A., Rushton, F., Ross, J. P., Jackson, J., Kapoian, T., ... Moran, J. A. (2002). Multicenter clinical trial results with the lifesite® hemodialysis access system. Kidney International, 62(3), 1026-1033. https://doi.org/10.1046/j.1523-1755.2002.00540.x

Multicenter clinical trial results with the lifesite® hemodialysis access system. / Schwab, Steve J.; Weiss, Mark A.; Rushton, Fred; Ross, John P.; Jackson, Jerry; Kapoian, Toros; Yegge, James; Rosenblatt, Melvin; Reese, Woody J.; Soundararajan, Ramesh; Work, Jack; Ross, Jamie Lynn; Stainken, Brian; Pedan, Alexander; Moran, John A.

In: Kidney International, Vol. 62, No. 3, 2002, p. 1026-1033.

Research output: Contribution to journalArticle

Schwab, SJ, Weiss, MA, Rushton, F, Ross, JP, Jackson, J, Kapoian, T, Yegge, J, Rosenblatt, M, Reese, WJ, Soundararajan, R, Work, J, Ross, JL, Stainken, B, Pedan, A & Moran, JA 2002, 'Multicenter clinical trial results with the lifesite® hemodialysis access system', Kidney International, vol. 62, no. 3, pp. 1026-1033. https://doi.org/10.1046/j.1523-1755.2002.00540.x
Schwab, Steve J. ; Weiss, Mark A. ; Rushton, Fred ; Ross, John P. ; Jackson, Jerry ; Kapoian, Toros ; Yegge, James ; Rosenblatt, Melvin ; Reese, Woody J. ; Soundararajan, Ramesh ; Work, Jack ; Ross, Jamie Lynn ; Stainken, Brian ; Pedan, Alexander ; Moran, John A. / Multicenter clinical trial results with the lifesite® hemodialysis access system. In: Kidney International. 2002 ; Vol. 62, No. 3. pp. 1026-1033.
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abstract = "Background. The LifeSite{\circledR} Hemodialysis Access System is a subcutaneous access device designed to maximize blood flow while minimizing access-related complications. The purpose of this study was to compare the efficacy and safety of the LifeSite System to a similar but transcutaneous access device, the Tesio-Cath{\circledR} Hemodialysis Catheter. Methods. The study was conducted in two phases. A multicenter randomized prospective design was utilized for the first phase (Phase 1) where thirty-four patients were enrolled in the Tesio-Cath group and 36 patients into the LifeSite group where 0.2{\%} sodium oxychlorosene was used as an antimicrobial solution for the LifeSite. A nonrandomized, but otherwise identical, second phase of the study followed where a 70{\%} isopropyl alcohol solution was utilized as the antimicrobial solution for 34 additional LifeSite patients (Phase 2). Results. Device function was evaluated in Phase 1 of the trial. Actual blood flow (determined by ultrasound dilution) was greater in the LifeSite versus the Tesio-Cath group (358.7 vs. 331.8 mL/min, P < 0.001 for machine-indicated blood flow of 400 mL/min). Infection comparisons were performed for all three groups encompassing Phase 1 and 2 of the trial; Tesio-Catheter, LifeSite System with oxychlorosene, and LifeSite System with 70{\%} isopropyl alcohol. Device-related infections were defined as systemic bacteremia without another obvious site of origin and exit site infections requiring systemic antibiotics or device removal. This revealed infection rates per 1000 device use days of 1.3 for the LifeSite alcohol group, 3.3 for the Tesio-Cath group, and 3.4 per for the LifeSite oxychlorosene group. There was no statistically significant difference in device related infection rates between the Tesio-Cath and the LifeSite oxychlorosene groups. There were significant differences in infection rate between LifeSite alcohol group and the other two groups (P < 0.05). Device thrombosis was defined by the need for instillation of thrombolytic agents to maintain blood flow >300 mL/min. There was no difference in the need for thrombolytic infusions between the LifeSite oxychlorosene group and the Tesio-Cath group (P = 0.1496); however, the LifeSite alcohol group required significantly fewer thrombolytic infusions than the Tesio-Cath group (P = 0.0295) to maintain adequate blood flow. Device survival at 6 months after stratification by diabetic status and adjusting for age was significantly better in the LifeSite alcohol group (89.9{\%}) than in the LifeSite oxychlorosene group (64.8{\%}, P = 0.0286) and in the Tesio-Cath (69.1{\%}, P = 0.0292) group. Conclusions. The LifeSite Hemodialysis Access System, when used with 70{\%} isopropyl alcohol as an antimicrobial solution, provides superior performance with a lower infection rate and better device survival than a standard cuffed tunneled hemodialysis catheter.",
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author = "Schwab, {Steve J.} and Weiss, {Mark A.} and Fred Rushton and Ross, {John P.} and Jerry Jackson and Toros Kapoian and James Yegge and Melvin Rosenblatt and Reese, {Woody J.} and Ramesh Soundararajan and Jack Work and Ross, {Jamie Lynn} and Brian Stainken and Alexander Pedan and Moran, {John A.}",
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TY - JOUR

T1 - Multicenter clinical trial results with the lifesite® hemodialysis access system

AU - Schwab, Steve J.

AU - Weiss, Mark A.

AU - Rushton, Fred

AU - Ross, John P.

AU - Jackson, Jerry

AU - Kapoian, Toros

AU - Yegge, James

AU - Rosenblatt, Melvin

AU - Reese, Woody J.

AU - Soundararajan, Ramesh

AU - Work, Jack

AU - Ross, Jamie Lynn

AU - Stainken, Brian

AU - Pedan, Alexander

AU - Moran, John A.

PY - 2002

Y1 - 2002

N2 - Background. The LifeSite® Hemodialysis Access System is a subcutaneous access device designed to maximize blood flow while minimizing access-related complications. The purpose of this study was to compare the efficacy and safety of the LifeSite System to a similar but transcutaneous access device, the Tesio-Cath® Hemodialysis Catheter. Methods. The study was conducted in two phases. A multicenter randomized prospective design was utilized for the first phase (Phase 1) where thirty-four patients were enrolled in the Tesio-Cath group and 36 patients into the LifeSite group where 0.2% sodium oxychlorosene was used as an antimicrobial solution for the LifeSite. A nonrandomized, but otherwise identical, second phase of the study followed where a 70% isopropyl alcohol solution was utilized as the antimicrobial solution for 34 additional LifeSite patients (Phase 2). Results. Device function was evaluated in Phase 1 of the trial. Actual blood flow (determined by ultrasound dilution) was greater in the LifeSite versus the Tesio-Cath group (358.7 vs. 331.8 mL/min, P < 0.001 for machine-indicated blood flow of 400 mL/min). Infection comparisons were performed for all three groups encompassing Phase 1 and 2 of the trial; Tesio-Catheter, LifeSite System with oxychlorosene, and LifeSite System with 70% isopropyl alcohol. Device-related infections were defined as systemic bacteremia without another obvious site of origin and exit site infections requiring systemic antibiotics or device removal. This revealed infection rates per 1000 device use days of 1.3 for the LifeSite alcohol group, 3.3 for the Tesio-Cath group, and 3.4 per for the LifeSite oxychlorosene group. There was no statistically significant difference in device related infection rates between the Tesio-Cath and the LifeSite oxychlorosene groups. There were significant differences in infection rate between LifeSite alcohol group and the other two groups (P < 0.05). Device thrombosis was defined by the need for instillation of thrombolytic agents to maintain blood flow >300 mL/min. There was no difference in the need for thrombolytic infusions between the LifeSite oxychlorosene group and the Tesio-Cath group (P = 0.1496); however, the LifeSite alcohol group required significantly fewer thrombolytic infusions than the Tesio-Cath group (P = 0.0295) to maintain adequate blood flow. Device survival at 6 months after stratification by diabetic status and adjusting for age was significantly better in the LifeSite alcohol group (89.9%) than in the LifeSite oxychlorosene group (64.8%, P = 0.0286) and in the Tesio-Cath (69.1%, P = 0.0292) group. Conclusions. The LifeSite Hemodialysis Access System, when used with 70% isopropyl alcohol as an antimicrobial solution, provides superior performance with a lower infection rate and better device survival than a standard cuffed tunneled hemodialysis catheter.

AB - Background. The LifeSite® Hemodialysis Access System is a subcutaneous access device designed to maximize blood flow while minimizing access-related complications. The purpose of this study was to compare the efficacy and safety of the LifeSite System to a similar but transcutaneous access device, the Tesio-Cath® Hemodialysis Catheter. Methods. The study was conducted in two phases. A multicenter randomized prospective design was utilized for the first phase (Phase 1) where thirty-four patients were enrolled in the Tesio-Cath group and 36 patients into the LifeSite group where 0.2% sodium oxychlorosene was used as an antimicrobial solution for the LifeSite. A nonrandomized, but otherwise identical, second phase of the study followed where a 70% isopropyl alcohol solution was utilized as the antimicrobial solution for 34 additional LifeSite patients (Phase 2). Results. Device function was evaluated in Phase 1 of the trial. Actual blood flow (determined by ultrasound dilution) was greater in the LifeSite versus the Tesio-Cath group (358.7 vs. 331.8 mL/min, P < 0.001 for machine-indicated blood flow of 400 mL/min). Infection comparisons were performed for all three groups encompassing Phase 1 and 2 of the trial; Tesio-Catheter, LifeSite System with oxychlorosene, and LifeSite System with 70% isopropyl alcohol. Device-related infections were defined as systemic bacteremia without another obvious site of origin and exit site infections requiring systemic antibiotics or device removal. This revealed infection rates per 1000 device use days of 1.3 for the LifeSite alcohol group, 3.3 for the Tesio-Cath group, and 3.4 per for the LifeSite oxychlorosene group. There was no statistically significant difference in device related infection rates between the Tesio-Cath and the LifeSite oxychlorosene groups. There were significant differences in infection rate between LifeSite alcohol group and the other two groups (P < 0.05). Device thrombosis was defined by the need for instillation of thrombolytic agents to maintain blood flow >300 mL/min. There was no difference in the need for thrombolytic infusions between the LifeSite oxychlorosene group and the Tesio-Cath group (P = 0.1496); however, the LifeSite alcohol group required significantly fewer thrombolytic infusions than the Tesio-Cath group (P = 0.0295) to maintain adequate blood flow. Device survival at 6 months after stratification by diabetic status and adjusting for age was significantly better in the LifeSite alcohol group (89.9%) than in the LifeSite oxychlorosene group (64.8%, P = 0.0286) and in the Tesio-Cath (69.1%, P = 0.0292) group. Conclusions. The LifeSite Hemodialysis Access System, when used with 70% isopropyl alcohol as an antimicrobial solution, provides superior performance with a lower infection rate and better device survival than a standard cuffed tunneled hemodialysis catheter.

KW - Cuffed tunneled hemodialysis catheter

KW - Dialysis catheter

KW - Hemodialysis

KW - Subcutaneous access device

KW - Transcutaneous access device

KW - Vascular access

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