Carlo briguori md phd laboratoy of interventional cardiology clinica mediterranea naples italy
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REMEDIAL II RE nal Insufficiency Following Contrast MEDIA Administration II Tria L RenalGuard system in high risk patients for contrast induced acute kidney injury. Carlo Briguori , MD, PhD Laboratoy of Interventional Cardiology Clinica Mediterranea , Naples - Italy.

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Carlo briguori md phd laboratoy of interventional cardiology clinica mediterranea naples italy l.jpg

REMEDIAL II REnal Insufficiency Following Contrast MEDIA Administration II TriaLRenalGuard system in high riskpatientsforcontrastinduced acute kidneyinjury

Carlo Briguori, MD, PhD

Laboratoy of Interventional Cardiology

ClinicaMediterranea, Naples - Italy


Disclosure statement of financial interest l.jpg

I, Carlo Briguori DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Disclosure Statement of Financial Interest


Background l.jpg
Background interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

  • Contrast-induced acute kidney injury (CI-AKI) is a powerful predictor of unfavorable early and late outcome1-3

  • Severalstudiesshowed the advantages of the prophylaxis by

    • sodium bicarbonate solution 4-5

    • N-acetylcysteine (NAC) 6-7

  • However, in high riskpatients the rate of CI-AKI isstill high

    1. McCullough PA. J Am CollCardiol 2008;51:1419-28

    2. Solomon R. et al. Clin J Am Soc Nephrol 2009;4:1162-1169

    3. Briguori C, et al. Circulation 2010;121:2117-2122.

    4. Merten GJ et al. JAMA 2004;291:2328-2334

    5. Briguori C, et al. Circulation 2007;115:1211-1217.

    6. Tepel M et al. N Engl J Med 2000;343:180-184.

    7. Trivedi H, et al. Am J Med 2009;122:874 e9-15


High risk patients l.jpg
High risk patients interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Mehran R et al J Am CollCardiol2004; 44:1393-9


Background5 l.jpg
Background interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

  • Creating and maintaining a high urine output is beneficial to prevent kidney damage. This high urine flow rate, indeed, should allow the body to rapidly eliminate contrast, reducing its toxic effects.

  • Data from the PRINCE study indicate thatincreasing the urine flow rate (≥150 ml/h) reduces the toxiceffectofcontrast media 1

  • A forced diuresis regime is usually achieved by high dose of furosemide which may be deleterious, potentially due to a negative fluid balance 2,3

    1. Stevens MA et al. J Am CollCardiol 1999;33:403-411

    2.Weinstein JM et al. Nephron 1992;62:413-415

    3. Solomon R, et al. N Engl J Med 1994;331:1416-1420.


Background6 l.jpg
Background interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

  • The RenalGuardTM automated hydration matching system (PLC Medical System, Inc.) was developed in order to achieve precise real-time high volume fluid balance using a closed loop hydration monitoring and infusion system


Renalguard system l.jpg
RenalGuard system interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Resnic F. et al. J Am CollCardiol2009 53: A36


Renalguard system8 l.jpg
RenalGuard System interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.


Renalguard system9 l.jpg
RenalGuard System interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

  • closed loop fluid management system

  • high volume fluid pump

  • high accuracy dual weight measuring system

  • single use intravenous set; urine collection system that interfaces with a standard Foley catheter

  • real-time display of urine and hydration fluid volume

  • user set net fluid gain and fluid bolus administration for patients that require re-hydration prior to and during the procedure

  • automatic battery back-up

  • automatic priming of infusion set

  • timely alerts to drain urine bag or to replace the hydration fluid bag.


Purpose l.jpg
Purpose interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

  • We performed a prospective, randomized study comparing the prophylactic effectiveness of 2 different strategies for preventing CI-AKI:

    • Sodium Bicarbonate plus N-Acetylcysteine (Control Group)

    • Hydration with RenalGuard system (RenalGuard Group)


Remedial ii l.jpg
REMEDIAL II interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

  • DESIGN: Prospective, randomized, double-arm, multicenters clinical study

Elective contrast media administration in patients at high risk for CI-AKI

(risk score ≥11 and/or eGFR≤30 ml/min/1.73 m2)

Control group

RenalGuard

group

CI-AKI

(sCr ≥0.3 mg/dL at 48 h)


Sample size l.jpg

Hypothesis: interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Reduction in the primary endpoint from 25% in the Control group to 10% in the RenalGuard group

Sample size:

A total of 266 patients (133 each group) will be necessary to gave the study 90% power and a significance level <0.05

Sample size


Inclusion criteria l.jpg
Inclusion criteria interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

  • Age 18 y

  • Chronic kidney disease

  • High risk for CI-AKI:

    • eGFR ≤30 ml/min/1.73 m2 and/or

    • Mehran score ≥ 11


Exclusion criteria l.jpg
Exclusion criteria interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

  • Primary or rescue PCI

  • Pregnancy

  • Recent (≤ 7 days) contrast media exposure

  • Chronic dialysis and/or history or previous dialysis

  • multiple myeloma

  • pulmonary edema

  • acute myocardial infarction

  • Administration of theophylline, dopamine, mannitol, or fenoldopam or sodium bicarbonate.


Slide15 l.jpg

REMEDIAL II trial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Sodium Bicardonate &

Acetylcysteine

RenalGuard group

Hydrationbysodiumbicarbonate

(3 ml/Kg i.v. 1 h before

and 1 ml/kg for 6 h after)

&

NAC 1200 mg BID x 2 &

1.5 g e.v.during the procedure

Hydrationwithnormal saline

(urine flow ≥ 300 ml/h)

&

NAC (1.5 g/L)

&

limited (0.25 mg/kg) furosemide dose


Slide16 l.jpg

RenalGuard interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. group

Pre-procedure

Procedure

Post- procedure

600

  • Biomarkers:

  • sCr = baseline, 2, 6, 12, 24 and 48 hours

  • sCyC = baseline, 2, 6, 12, 24 and 48 hours

  • NGAL = baseline, 2, 6, 12, 24 and 48 hours

500

Foley Catheter

RenalGuard system

Prime (≤250 mL)

400

Furosemide (0.25 mg/kg)

Urine flow rate (ml/h)

300

200

Continuous real-time matched replacement fluid

100

0

0

30

60

90

120

150

180

210

240

270

300

330

360

400

Time (minutes)

Patient ready for

procedure when

urine flow rate

is ≥300 ml/h


Renalguard system17 l.jpg
RenalGuard System interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.


Endpoints l.jpg

Primary endpoint interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.:

Rate of CI-AKI, defined as a serum creatinine (sCr) increase 0.3 mg/dLat48 hours

Secondary endpoints:

an increase in the sCr concentration 25% and 0.5 mg/dl at 48 hours after contrast exposure

changes in the serum cystatin C (sCyC) concentration at 24 and 48 hours after contrast exposure

the rate of acute renal failure requiring dialysis

the rate of in-hospital, and 1 month major adverse events (MAE), including a) death, b) renal failure requiring dialysis, and c) acute pulmonary edema

changes in the serum and urine NGAL concentrations at 2, 6, 12, 24 and 48 hours after contrast exposure

Endpoints


Slide19 l.jpg

Assessed for eligibility ( n= 806) interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Exclusion (n = 512)

Not meeting inclusion/exclusion criteria (n = 485 )

Refused to partecipate (n = 27)

Enrollement

Randomized (n = 294)

  • Patients allocated in the RenalGuard group (n = 147)

    • Received allocated treatment (n = 146)

    • Did not receive the allocated treatment (n =1)

  • Patients allocated in the Control group (n = 147)

    • Received allocated treatment (n = 146)

    • Did not receive the allocated treatment (n= 1)

Allocation

Patients lost at follow-up (n = 0)

Discontinued treatement (n = 0)

Patients lost at follow-up (n = 0)

Discontinued treatment (n = 2)

Follow-up

Analysis

Patients analized ( n = 146)

Patients excluded from analysis (n = 0)

Patients analized ( n = 146)

Patients excluded from analysis (n = 0)


Clinical characteristics l.jpg
Clinical Characteristics interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.


Biochemical characteristics l.jpg
Biochemical Characteristics interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.


Procedural characteristics l.jpg
Procedural Characteristics interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.


Slide23 l.jpg

Distribution interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.of the Risk score

120

100

72.5%

80

Number of patients

60

40

20

2%

13%

12.5%

0

≥5

≥6-10

≥11-15

≥16

Risk score


Slide24 l.jpg

3000 interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

p <0.001

2500

2000

1500

1000

500

0

Control Group

RenalGuard group

Urine Volume at 24 hours


Slide25 l.jpg

RenalGuard interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. group

Pre-procedure

Procedure

Post- procedure

7 h & 54 minutes (4.7-11.5 h)

600

  • Biomarkers:

  • sCr = baseline, 2, 6, 12, 24 and 48 hours

  • sCyC = baseline, 2, 6, 12, 24 and 48 hours

  • NGAL = baseline, 2, 6, 12, 24 and 48 hours

500

400

Foley Catheter

RenalGuard system

Prime (223±45 mL; range = 50-300)

Urine flow rate (ml/h)

Furosemide (14±8mg; range = 0-50)

300

200

Continuous real-time matched replacement fluid

100

0

0

30

60

90

120

150

180

210

240

270

300

330

360

400

Time (minutes)

Time to reach

Target urine flow rate

58±19 min (30-120)


Slide26 l.jpg

4000 interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

3500

3000

2500

infusion

Volume(ml)

2000

1500

urine

1000

500

0

15

45

75

105

135

165

195

225

255

285

315

345

375

Time (minutes)

RenalGuard Group


Slide27 l.jpg

900 interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

800

700

600

500

400

300

200

100

0

15

45

75

105

135

165

195

225

255

285

315

345

375

RenalGuard Group

  • Mean urine flow rate:

  • 352±131 ml/h

  • Target reached in 93%

  • of patients (416±19 ml/h)

  • Below the target in 7%

  • of patients (117±48 ml/h)

Urine flow rate (ml/h)

Time (minutes)


Slide28 l.jpg

sCr interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.kinetic

2.4

2.2

2.0

1.8

serum creatinine (median)

1.6

1.4

Control group

1.2

p = 0.008; F = 4.97

RenalGuard group

1.0

Baseline

24

48

Time (hours)


Slide29 l.jpg

30/146 interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

16/146

Primaryendpoint

Odds ratio = 0.47; 95% CI= 0.24-0.92

p = 0.025

25

20.5%

20

15

CI-AKI (%)

11%

10

5

0

Control group

RenalGuard group


Slide30 l.jpg

Secondary interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.endpoints


Slide31 l.jpg

sCyC interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.kinetic

2.4

2.2

2.0

1.8

serum cystatin C (median)

1.6

1.4

Control group

1.2

p = 0.004; F = 5.52

RenalGuard group

1.0

Baseline

24

48

Time (hours)


Slide32 l.jpg

Control Group interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

RenalGuard Group

Secondaryendpoint

Events rate at 1-month

p = 0.52

9.6

10

9

8

6.8

7

p = 0.031

p = 1.0

6

4.8

%

5

4.1

4.1

4

p = 0.62

3

2.1

2

0.7

0.7

1

0

Dialysis

Pulmonary

Edema

Death

Cumulative


Conclusions l.jpg
Conclusions interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

The RenalGuard therapy, including hydration with normal saline plus high dose of NAC controlled by the RenalGuard system in combination with limited (0.25 mg/kg) dose of furosemide, is an effective renoprotective strategy for patients at high- risk for CI-AKI.


Remedial ii investigators l.jpg

Clinica Mediterranea, Naples interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

C. Briguori (P.I.)

A. Focaccio

G. Visconti

B. Golia

REMEDIAL II Investigators

  • University of Ferrara, Ferrara

    • M. Valgimigli

    • R. Ferrari

  • Multimedica IRCCS, Milan

    • F. Airoldi

    • D. Tavano

    • S. Di Biase

    • S. Bertoli

  • University of Modena, Modena

    • G.M. Sangiorgi

    • M. G. Modena


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