NCT01879839

Effect of a Pre-interventional Diet on Renal Function After Administration of Contrast Agent in Patients at Risk

Phase 4 Study of Effect of a Pre-interventional Calorie Restriction on Renal Function After Administration of Contrast Agent in Patients at Risk

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the effect of a diet prior to administration of contrast agent in terms of a preventive procedure which leads to an attenuation of the contrast-induced nephropathy (CIN). Patients with a known kidney disease are especially at risk. A potential beneficial effect of a diet prior to intervention has been shown in investigations in mammals, therefore this study will investigate if a pre-interventional diet in patients with known kidney disease and scheduled contrast agent examination can attenuate or prevent a post-interventional loss of kidney function.

Detailed description

Patients with contrast agent examinations are at risk for contrast-induced nephropathy (CIN) and in succession acute renal failure which is associated with significant morbidity and mortality. None of the currently used preventive procedures show a benefit in terms of a CIN-prevention. Experimental data suggests, that a pre-interventional caloric restriction might provide kidney protection in this context. This clinical trial investigates if this phenomenon is also applicable in humans. Patients with increased risk for a post-interventional renal failure due to known chronic kidney disease are randomized in 2 groups. Patients of the diet group receive a calorie restriction to 60% of the calculated daily energy rate from day -4 until day -1 (included) pre-intervention (day 0 corresponds to day of intervention). Patients of the control group receive alimentation ad libitum. Primary objective is the increase of serum creatinine in mg/dl 48 h after begin of intervention in comparison to baseline value obtained in the morning of the day of intervention (day 0) in order to analyse if a pre-interventional calorie restriction as a preventive strategy leads to an attenuation of post-interventioal kidney injury. Hypothesis: A four day calorie restriction reduces the increase of serum creatinine after administration of contrast agent in patients with known chronic kidney disease.

Conditions

• Renal Failure Chronic Contrast Induced

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Diet	Patients receive special diet 4 days prior to contrast-agent administration.

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2013-06-18
• Last updated: 2019-08-09

Locations

1 site across 1 country: Germany