NCT00130598

Brief Summary

Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2005

Typical duration for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 5, 2010

Status Verified

March 1, 2010

Enrollment Period

4.5 years

First QC Date

August 12, 2005

Last Update Submit

March 4, 2010

Conditions

Kidney Failure, Acute

Keywords

contrast nephropathycontrast mediarenal dysfunction

Outcome Measures

Primary Outcomes (1)

  • Decrease in glomerular filtration rate (GFR) within 48 hours. GFR is calculated using the abbreviated Modification of Diet in Renal Disease (MDRD) Study equation.

    48 hours

Secondary Outcomes (11)

  • Development of contrast nephropathy, defined as an increase >=25% in the baseline serum creatinine concentration within 48 hours

    48 hours

  • Development of contrast nephropathy, defined as an increase >=44umol/l in serum creatinine concentration within 48 hours

    48 hours

  • Development of contrast nephropathy, defined as an increase >=25% in the baseline serum cystatin C concentration or an increase >=0.35mg/l in serum cystatin C concentration within 48 hours

    48 hours

  • Postcontrast increase in serum cystatin C at day 1 and 2

    48 hours

  • In-hospital morbidity (nonfatal myocardial infarction) and mortality

    60 days

  • +6 more secondary outcomes

Study Arms (3)

1

ACTIVE COMPARATOR

control group: patients receive a preventive hydration with 154mEq/l saline at an ongoing rate of 1ml/kg per hour of at least 12 hours prior and after the procedure.

Drug: NaCl 0.9% i.v. or NaBic 1.4% i.v. or NaBic 1.4% i.v. + NaBic p.o. (Nephrotrans®)

2

ACTIVE COMPARATOR

7h-sodium bicarbonate (according to the regimen used in a recently published study (slightly modified)14): before contrast a bolus of 3ml/kg NaHCO3 166mEq/l for one hour, followed by an infusion of NaHCO3 166mEq/l with a rate of 1ml/kg per hour until 6h after contrast.

Drug: NaCl 0.9% i.v. or NaBic 1.4% i.v. or NaBic 1.4% i.v. + NaBic p.o. (Nephrotrans®)

3

ACTIVE COMPARATOR

short-term sodium bicarbonate: NaHCO3 166mEq/l (3ml/kg; patients with a body weight above 100kg 300ml) as a bolus 20 minutes before contrast; additionally ingestion of Nephrotrans® (500mg NaHCO3/capsule: 1 capsule/10kg) with 1-2 dl of San Pellegrino® non-sparkling mineral water at the start of the infusion. Ingestion of 500ml San Pellegrino® non-sparkling mineral water in the first 6 hours after contrast.

Drug: NaCl 0.9% i.v. or NaBic 1.4% i.v. or NaBic 1.4% i.v. + NaBic p.o. (Nephrotrans®)

Interventions

NaCl 0.9% i.v. or NaBic 1.4% i.v. or NaBic 1.4% i.v. + NaBic p.o. (Nephrotrans®)DRUG

control group: preventive hydration with 154mEq/l saline at 1ml/kg per hour of 12 hours prior and after the procedure. 7h-sodium bicarbonate: before contrast 3ml/kg NaHCO3 166mEq/l for one hour, followed by NaHCO3 166mEq/l (1ml/kg per hour until 6h after contrast). short-term sodium bicarbonate: NaHCO3 166mEq/l (3ml/kg) as a bolus 20 minutes before contrast; ingestion of Nephrotrans® (500mg NaHCO3/capsule: 1 capsule/10kg) with 1-2 dl non-sparkling mineral water at the start of the infusion. Ingestion of non-sparkling mineral water in the first 6 hours after contrast.

Also known as: NaCl 0.9% Braun®, NaBic 1.4% Bichsel®, Nephrotrans®
123

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted with renal dysfunction (baseline serum creatinine level above the upper limit of normal of the serum creatinine \[\>93umol/l for women and \>117umol/l for men\] or GFR \<60ml/min \[GFR calculated using the abbreviated MDRD study equation\]) scheduled to undergo an intraarterial or intravenous radiographic contrast procedure within the next 24 hours.

You may not qualify if:

  • Age \<18 years
  • Preexisting dialysis
  • Allergy to radiographic contrast
  • Pregnancy (women \< 50 years: pregnancy test required)
  • Severe heart failure (New York Heart Association \[NYHA\] III-IV)
  • N-acetylcysteine \</= 24 hours before contrast
  • Clinically vulnerable condition requiring continuous fluid therapy e.g. severe sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

University Hospital of Basel

Basel, Basel, 4031, Switzerland

Location

Kantonsspital Liestal - Universitätskliniken

Liestal, 4100, Switzerland

Location

Related Publications (4)

  • Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.

    PMID: 15150204BACKGROUND

  • Mueller C, Seidensticker P, Buettner HJ, Perruchoud AP, Staub D, Christ A, Buerkle G. Incidence of contrast nephropathy in patients receiving comprehensive intravenous and oral hydration. Swiss Med Wkly. 2005 May 14;135(19-20):286-90. doi: 10.4414/smw.2005.10938.

    PMID: 15986266BACKGROUND

  • Mueller C, Buerkle G, Buettner HJ, Petersen J, Perruchoud AP, Eriksson U, Marsch S, Roskamm H. Prevention of contrast media-associated nephropathy: randomized comparison of 2 hydration regimens in 1620 patients undergoing coronary angioplasty. Arch Intern Med. 2002 Feb 11;162(3):329-36. doi: 10.1001/archinte.162.3.329.

    PMID: 11822926BACKGROUND

  • Klima T, Christ A, Marana I, Kalbermatter S, Uthoff H, Burri E, Hartwiger S, Schindler C, Breidthardt T, Marenzi G, Mueller C. Sodium chloride vs. sodium bicarbonate for the prevention of contrast medium-induced nephropathy: a randomized controlled trial. Eur Heart J. 2012 Aug;33(16):2071-9. doi: 10.1093/eurheartj/ehr501. Epub 2012 Jan 19.

    PMID: 22267245DERIVED

Related Links

MeSH Terms

Conditions

Acute Kidney InjuryRenal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Christian Mueller, Prof.

    University Hospital of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 12, 2005

First Posted

August 15, 2005

Study Start

June 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 5, 2010

Record last verified: 2010-03

Locations

CH(2)IT(1)