NCT02643602

Brief Summary

Contrast-induced nephropathy (CIN) is the third most frequent cause of hospital-acquired acute renal failure. Different regimes in the prophylaxis of CIN have been investigated in the last years. Recent Meta-analysis show a reduced incidence of CIN when theophylline is administered to the patients especially in patients with already existing renal impairment. Furthermore hydration with bicarbonate seems to to be superior to hydration with sodium chloride alone. The combination of the two prophylaxis has not been investigated yet. Aim of this prospective randomized trial is to investigate the effect of hydration with sodium bicarbonate compared to saline in addition to theophylline prophylaxis which all patients receive.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

6.5 years

First QC Date

December 23, 2015

Last Update Submit

December 30, 2015

Conditions

Radiographic Contrast Agent Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Contrast induced nephropathy

    Raise in serum creatinine of ≥25% or ≥0.5 mg/dl

    48 hours

Secondary Outcomes (9)

  • Change of serum creatinine levels over time

    48 hours

  • Change of creatinine clearance over time

    48 hours

  • Change in blood pH

    48 hours

  • Change in blood bicarbonate-concentration

    48 hours

  • Change in blood sodium-concentration

    48 hours

  • +4 more secondary outcomes

Study Arms (2)

Bicarbonate and theophylline

EXPERIMENTAL

Hydration with bicarbonate in addition to theophylline

Other: Hydration with bicarbonate in addition to theophylline

Sodium and theophylline

ACTIVE COMPARATOR

Hydration with sodium chloride in addition to theophylline

Other: Hydration with sodium chloride in addition to theophylline

Interventions

Hydration with bicarbonate in addition to theophyllineOTHER

0.154-molar sodium bicarbonate; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours

Bicarbonate and theophylline
Hydration with sodium chloride in addition to theophyllineOTHER

0.9% sodium chloride; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours

Sodium and theophylline

Eligibility Criteria

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

You may qualify if:

  • Increased risk for contrast induced nephropathy defined as:
  • Serum creatinine level ≥ 1.1 mg/dl OR
  • Serum creatinine level ≥ 0.8 mg/dl plus an additional risk factor like diabetes mellitus, renal failure in past medical history or nephrotoxic medication (aminoglycoside, vancomycin, amphotericin B, diuretic)

You may not qualify if:

  • pre-existing renal replacement therapy
  • unstable serum creatinine levels (difference of more than ±0.4 mg/dl within 3 days before contrast application)
  • contraindications for theophylline or sodium bicarbonate (allergies, tachycardia, alkalosis, hypokalemia)
  • additional interventions that might influence renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

BicarbonatesSodium Chloride

Intervention Hierarchy (Ancestors)

CarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsAnionsIonsElectrolytesChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Officials

  • Wolfgang Huber, M.D.

    2. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2015

First Posted

December 31, 2015

Study Start

December 1, 2005

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

January 1, 2016

Record last verified: 2015-12