Bicarbonate v Saline to Prevent Contrast Nephropathy

Status Terminated

Clinical Trial Summary

Slowing of kidney function occurs in a minority of people given dye during angiography. The purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury: salt in water or baking soda in water.

Clinical Trial Description

A decline in kidney function after contrast is associated with prolonged hospital stay, adverse cardiac events, and higher mortality both in hospital and in the long term. Deliberate administration of fluids is recommended to reduce the risk of contrast nephropathy. However, data to support specific recommendations are lacking and the optimal fluid regimen remains unclear.

It has been hypothesized that alkalinization of tubular fluid might be beneficial by reducing pH dependent free radical levels. A recent trial found a lower frequency of creatinine rise > 25% within two days of contrast with a 7 hour infusion of isotonic sodium bicarbonate than with saline infusion (Merten GJ, JAMA 2004). However, it remains to be proven that bicarbonate is superior as this trial has a number of methodological flaws.

Comparison: IV 1/6 M sodium bicarbonate OR IV 0.9% saline, each isotonic fluid given at the same rate of sodium administration (3.25 ml/Kg over 1 hour pre-contrast, followed by 1.1 ml/Kg/hr for 6 hours for bicarbonate; 3.5 ml/Kg over 1 hour pre-contrast, followed by 1.2 ml/Kg/hr for 6 hours for saline). Total infusion time 7 hours (for both). Maximum rate of fluid permitted is that for a body weight of 110 Kg. Intra-vascular iso- or low-osmolality contrast in the minimal dose needed to complete the required imaging. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00384995
Study type	Interventional
Source	Italian Society of Nephrology
Contact
Status	Terminated
Phase	Phase 4
Start date	December 2006
Completion date	July 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00982527` - Fenoldopam in Pediatric Cardiac Surgery	Phase 3
Completed	`NCT00908843` - Prevention of Contrast Induced Nephropathy (NIC) by Intravenous Versus Oral Rehydration	N/A
Completed	`NCT00654992` - Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery	Phase 2/Phase 3
Completed	`NCT05407272` - Explore the Sharing Model Intervene to Improve the Knowledge, Attitudes, Service Intentions and Service Start-up Effects of the Eight Major Non-cancer Disease End-stage Caregivers on Well-being and Palliative Care	N/A
Not yet recruiting	`NCT05399420` - Study of Kidney Circulating Cell-free DNA in Patients With Acute Kidney Failure
Recruiting	`NCT04334707` - Kidney Precision Medicine Project
Completed	`NCT04072432` - A Study of RBT-3 in Healthy Volunteers and Volunteers With Stage 3-4 Chronic Kidney Disease	Phase 1
Recruiting	`NCT00230412` - Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)	N/A
Completed	`NCT00148044` - Uremic Toxins of Patients With Acute Kidney Failure	N/A
Active, not recruiting	`NCT04450095` - Effects of Endothelin Receptor Antagonist on Ischemic Kidney Injury During Nephron Sparing Surgery	Phase 2
Terminated	`NCT05747053` - Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
Completed	`NCT03353389` - Review of Trend in Incidence and Characteristics of Hospital-acquired Acute Kidney Injury in Hospital Selayang
Completed	`NCT03727581` - Ultrasound for Guidewire Detection
Completed	`NCT00912184` - Study Comparing High Cut-off Haemofiltration With Standard Haemofiltration in Acute Renal Failure	Phase 1/Phase 2
Recruiting	`NCT00522756` - Preventing Acute Renal Failure After Cardiac Surgery in High Risk Patients Using Sodium Bicarbonate Therapy	Phase 3
Completed	`NCT00484354` - Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery	Phase 2
Terminated	`NCT00316576` - Angiotensin-Converting Enzyme Polymorphism and Acute Renal Failure (ECAREA)	N/A
Completed	`NCT00122018` - An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery	Phase 2
Unknown status	`NCT01359722` - N-acetylcysteine to Prevent Renal Failure	N/A
Completed	`NCT00286273` - Safety and Efficacy of the Use of Regional Anticoagulation With Citrate in Continuous Venovenous Hemofiltration	Phase 4