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The Effect of Sodium Nitrite on Renal Function and Blood Pressure in Healthy Humans. A Dose-response Study

NCT02078908 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-10-09

No results posted yet for this study

Summary

The purpose of this study is to investigate the effect of different doses of sodium nitrite infusion in 12 healthy subjects. The effects on renal handling of nitrite, nitrate, sodium and water, plasma concentrations of vasoactive hormones, peripheral (brachial) and central blood pressure will be evaluated.

Hypothesis

Sodium nitrite infusion

1. increases urinary sodium excretion and renal filtration rate
2. lowers blood pressure, central as well as peripheral
3. affects vasoactive hormones
4. it is possible to establish a dose that affects the renal function with only minor effect on the blood pressure.

Conditions

  • Healthy

Interventions

DRUG

Sodium nitrite, 40 micrograms/kg/hour

Continuous 2 hour infusion of sodium nitrite, 40 micrograms/kg/hour

DRUG

Sodium nitrite, 120 micrograms/kg/hour

Continuous 2 hour infusion of sodium nitrite, 120 micrograms/kg/hour

DRUG

Sodium nitrite, 240 micrograms/kg/hour

Continuous 2 hour infusion of sodium nitrite, 240 micrograms/kg/hour

DRUG

Placebo

Continuous 2 hour infusion of sodium chloride, 25 ml/hour

Sponsors & Collaborators

  • Erling Bjerregaard Pedersen

    lead OTHER

Principal Investigators

  • Jesper N Bech, MD, PhD · Regional Hospital Holstebro

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02078908 on ClinicalTrials.gov