Abstract
Central venous catheters are used frequently in patients on hemodialysis as a bridge to a permanent vascular access. They are prone to frequent complications, including catheter-related bloodstream infection, catheter dysfunction, and central vein obstruction. There is a compelling need to develop new drugs or devices to prevent central venous catheter complications. We convened a multidisciplinary panel of experts to propose standardized definitions of catheter end points to guide the design of future clinical trials seeking approval from the Food and Drug Administration. Our workgroup suggests diagnosing catheter-related bloodstream infection in catheter-dependent patients on hemodialysis with a clinical suspicion of infection (fever, rigors, altered mental status, or unexplained hypotension), blood cultures growing the same organism from the catheter hub and a peripheral vein (or the dialysis bloodline), and absence of evidence for an alternative source of infection. Catheter dysfunction is defined as the inability of a central venous catheter to (1) complete a single dialysis session without triggering recurrent pressure alarms or (2) reproducibly deliver a mean dialysis blood flow of >300 ml/min (with arterial and venous pressures being within the hemodialysis unit parameters) on two consecutive dialysis sessions or provide a Kt/V≥1.2 in 4 hours or less. Catheter dysfunction is defined only if it persists, despite attempts to reposition the patient, reverse the arterial and venous lines, or forcefully flush the catheter. Central vein obstruction is suspected in patients with >70% stenosis of a central vein by contrast venography or the equivalent, ipsilateral upper extremity edema, and an existing or prior history of a central venous catheter. There is some uncertainty about the specific criteria for these diagnoses, and the workgroup has also proposed future high-priority studies to resolve these questions.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 495-500 |
| Number of pages | 6 |
| Journal | Clinical Journal of the American Society of Nephrology |
| Volume | 13 |
| Issue number | 3 |
| DOIs | |
| State | Published - Mar 7 2018 |
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Keywords
- Bacteremia
- Blood Culture
- Catheter-Related Infections
- Central vein
- Central Venous Catheters
- Chills
- Constriction
- Dialysis access
- Edema
- Humans
- Hypotension
- Pathologic
- Phlebography
- Renal dialysis
- Uncertainty
- United States
- United States Food and Drug Administration
- Vascular access
- Veins
- Venous Pressure
ASJC Scopus subject areas
- Epidemiology
- Critical Care and Intensive Care Medicine
- Nephrology
- Transplantation
Cite this
Recommended clinical trial end points for dialysis catheters. / Allon, Michael; Brouwer-Maier, Deborah J.; Abreo, Kenneth; Baskin, Kevin M.; Bregel, Kay; Chand, Deepa H.; Easom, Andrea M.; Mermel, Leonard; Mokrzycki, Michele H.; Patel, Priti R.; Roy-Chaudhury, Prabir; Shenoy, Surendra; Valentini, Rudolph P.; Wasse, Haimanot.
In: Clinical Journal of the American Society of Nephrology, Vol. 13, No. 3, 07.03.2018, p. 495-500.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Recommended clinical trial end points for dialysis catheters
AU - Allon, Michael
AU - Brouwer-Maier, Deborah J.
AU - Abreo, Kenneth
AU - Baskin, Kevin M.
AU - Bregel, Kay
AU - Chand, Deepa H.
AU - Easom, Andrea M.
AU - Mermel, Leonard
AU - Mokrzycki, Michele H.
AU - Patel, Priti R.
AU - Roy-Chaudhury, Prabir
AU - Shenoy, Surendra
AU - Valentini, Rudolph P.
AU - Wasse, Haimanot
PY - 2018/3/7
Y1 - 2018/3/7
N2 - Central venous catheters are used frequently in patients on hemodialysis as a bridge to a permanent vascular access. They are prone to frequent complications, including catheter-related bloodstream infection, catheter dysfunction, and central vein obstruction. There is a compelling need to develop new drugs or devices to prevent central venous catheter complications. We convened a multidisciplinary panel of experts to propose standardized definitions of catheter end points to guide the design of future clinical trials seeking approval from the Food and Drug Administration. Our workgroup suggests diagnosing catheter-related bloodstream infection in catheter-dependent patients on hemodialysis with a clinical suspicion of infection (fever, rigors, altered mental status, or unexplained hypotension), blood cultures growing the same organism from the catheter hub and a peripheral vein (or the dialysis bloodline), and absence of evidence for an alternative source of infection. Catheter dysfunction is defined as the inability of a central venous catheter to (1) complete a single dialysis session without triggering recurrent pressure alarms or (2) reproducibly deliver a mean dialysis blood flow of >300 ml/min (with arterial and venous pressures being within the hemodialysis unit parameters) on two consecutive dialysis sessions or provide a Kt/V≥1.2 in 4 hours or less. Catheter dysfunction is defined only if it persists, despite attempts to reposition the patient, reverse the arterial and venous lines, or forcefully flush the catheter. Central vein obstruction is suspected in patients with >70% stenosis of a central vein by contrast venography or the equivalent, ipsilateral upper extremity edema, and an existing or prior history of a central venous catheter. There is some uncertainty about the specific criteria for these diagnoses, and the workgroup has also proposed future high-priority studies to resolve these questions.
AB - Central venous catheters are used frequently in patients on hemodialysis as a bridge to a permanent vascular access. They are prone to frequent complications, including catheter-related bloodstream infection, catheter dysfunction, and central vein obstruction. There is a compelling need to develop new drugs or devices to prevent central venous catheter complications. We convened a multidisciplinary panel of experts to propose standardized definitions of catheter end points to guide the design of future clinical trials seeking approval from the Food and Drug Administration. Our workgroup suggests diagnosing catheter-related bloodstream infection in catheter-dependent patients on hemodialysis with a clinical suspicion of infection (fever, rigors, altered mental status, or unexplained hypotension), blood cultures growing the same organism from the catheter hub and a peripheral vein (or the dialysis bloodline), and absence of evidence for an alternative source of infection. Catheter dysfunction is defined as the inability of a central venous catheter to (1) complete a single dialysis session without triggering recurrent pressure alarms or (2) reproducibly deliver a mean dialysis blood flow of >300 ml/min (with arterial and venous pressures being within the hemodialysis unit parameters) on two consecutive dialysis sessions or provide a Kt/V≥1.2 in 4 hours or less. Catheter dysfunction is defined only if it persists, despite attempts to reposition the patient, reverse the arterial and venous lines, or forcefully flush the catheter. Central vein obstruction is suspected in patients with >70% stenosis of a central vein by contrast venography or the equivalent, ipsilateral upper extremity edema, and an existing or prior history of a central venous catheter. There is some uncertainty about the specific criteria for these diagnoses, and the workgroup has also proposed future high-priority studies to resolve these questions.
KW - Bacteremia
KW - Blood Culture
KW - Catheter-Related Infections
KW - Central vein
KW - Central Venous Catheters
KW - Chills
KW - Constriction
KW - Dialysis access
KW - Edema
KW - Humans
KW - Hypotension
KW - Pathologic
KW - Phlebography
KW - Renal dialysis
KW - Uncertainty
KW - United States
KW - United States Food and Drug Administration
KW - Vascular access
KW - Veins
KW - Venous Pressure
UR - http://www.scopus.com/inward/record.url?scp=85042482685&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85042482685&partnerID=8YFLogxK
U2 - 10.2215/CJN.12011116
DO - 10.2215/CJN.12011116
M3 - Article
C2 - 28729382
AN - SCOPUS:85042482685
VL - 13
SP - 495
EP - 500
JO - Clinical Journal of the American Society of Nephrology
JF - Clinical Journal of the American Society of Nephrology
SN - 1555-9041
IS - 3
ER -