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Contrast-induced Nephropathy clinical trials

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NCT ID: NCT04627831 Withdrawn - Clinical trials for Contrast-induced Nephropathy

Comparison of Captisol-Enabled™ Iohexol and Omnipaque™ in Patients With Impaired Renal Function Undergoing Coronary Angiography

Start date: January 2022
Phase: Phase 2
Study type: Interventional

Randomized parallel group study comparing the renal safety of Captisol-Enabled™ Iohexol (CE-Iohexol) Injection and Omnipaque™ (Iohexol) Injection in patients with impaired renal function undergoing coronary angiography.

NCT ID: NCT04603261 Withdrawn - Acute Kidney Injury Clinical Trials

Time to Excretion of Contrast, a Maastricht Prospective Observational Study

TEMPOS
Start date: November 1, 2097
Phase:
Study type: Observational

Risk of contrast-induced kidney injury is expected to be strongly correlated with exposure time. Studies on the excretion of iodinated contrast material are few and have mostly been carried out in patients with normal renal function. Although case wise reports of persistent renograms have been published, it is not known how long contrast is retained before excretion in patients with eGFR <30 mL/min/1.73m2, nor which of these patients are most susceptible to contrast retention. The current observational study aims to compare contrast elimination time and % contrast excretion in patients with eGFR <30 mL/min/1.73m2, to matched patients (for age, sex and contrast procedure type) with eGFR 30-59 and eGFR >=60 mL/min/1.73m2.

NCT ID: NCT04598516 Withdrawn - Renal Insufficiency Clinical Trials

Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30

MIRACLE
Start date: November 1, 2097
Phase:
Study type: Observational

Intravascular iodinated contrast administration has become crucial to modern medicine. Currently it is estimated that over 250 million injections are given each year worldwide during medical scans and interventions. An acute predefined increase in serum creatinine is considered an indicator of acute kidney injury (AKI). When such an acute increase in serum creatinine occurs within 5 days post-contrast in absence of another aetiology, it is assumed to be iodinated contrast administration induced acute kidney injury. For over 50 years now, acute kidney injury caused by intravascular administration of iodinated contrast material has been considered a leading cause of hospital-acquired renal failure. Contrast has been withheld in fear of kidney injury with misdiagnoses and delayed appropriate patient management as a result. Since 2018, it is now widely accepted that only patients with eGFR <30 mL/min/1.73m2 are at risk of renal injury after intravascular iodinated contrast material injection. However, no study to date has been able to distinguish acute kidney injury caused by iodinated contrast administration from that for which no causal link is established, and it is unsure a causal relationship exists. There are several studies, in attempts to evaluate the causal relationship between contrast exposure and nephrotoxicity, that found fluctuations in absence of contrast similar to those considered to be contrast-induced acute kidney injury. Similarly, it is unsure whether longer-term negative outcomes are inherent to the population studied or a result of contrast administration. However, most of these studies are observational and retrospective in nature. The issue with retrospective studies is that they often cannot control for confounders and therefore cannot give us causation, only association. On the other hand, prospective randomized controlled trials comparing intravascular iodinated contrast administration to no contrast are unlikely given evident ethical issues. The current prospective observational study proposes to use intra-patient comparisons of peak change in renal function during periods in absence of- and with contrast to elucidate the relationship between renal function and contrast administration in this population.

NCT ID: NCT04597892 Withdrawn - Acute Kidney Injury Clinical Trials

Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast

EPIC
Start date: May 1, 2097
Phase:
Study type: Observational

Point-of-care (POC) creatinine devices allow rapid measurement of creatinine levels and calculation of estimated glomerular filtration rate (eGFR) which give an indication of renal function. The focus of this assessment is to validate POC measurements to assess kidney function before intravascular iodinated contrast administration in patients with severe renal insufficiency (eGFR < 30 ml/min/1.73m2). It will be evaluated whether discrepancies between POC measurement values and values obtained from standard laboratory assays lie within an acceptable range using Bland-Altman analysis.

NCT ID: NCT03806725 Withdrawn - Acute Kidney Injury Clinical Trials

Safety of Iodinated Contrast in Liver Transplant Candidates With Decreased Renal Function Undergoing Coronary CT Angiography

Start date: June 1, 2020
Phase:
Study type: Observational

This study evaluates the safety of iodinated contrast medium administered to liver transplant candidates with decreased renal function undergoing coronary CT angiography. Incidence of post-contrast acute kidney injury in liver transplant candidates with decreased renal function and normal renal function will be compared.

NCT ID: NCT03136458 Withdrawn - Clinical trials for Contrast-induced Nephropathy

Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR)

PAIR
Start date: January 1, 2016
Phase: N/A
Study type: Interventional

This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy. All of the patients will receive endovenous normal saline to prevent nephropathy, half of the patients will receive remote ischemic preconditioning while the other half will not.

NCT ID: NCT01144091 Withdrawn - Diabetes Mellitus Clinical Trials

Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography

Start date: December 2012
Phase: N/A
Study type: Interventional

The investigators will study 2 separate groups: - Cardiology patients undergoing invasive coronary angiography +/- PCI (Percutaneous coronary intervention). - Patients undergoing CT examination with contrast medium. All patients will receive intravenous (I.V) hydration for 8-12h before and 36 to 48 h after angiography with 0.45% saline 100ml/h. All patients will receive oral N-acetyl cysteine 1200 mg twice daily, a day before, on the day of the angiography and for another 48 hours. In addition, patients will be assigned to receive oral pentoxyphylline (P group) or placebo (C - control group) tablets 3 times a day one day before, on the day of the procedure and for another 48 hours. Baseline Serum Creatinine (S.Cr) levels in will be taken before angiography and two days after angiography. Radio-contrast nephropathy is defined, in this study, as increase in serum ≥ 25 % of baseline after injection of the radio-contrast agent. Pentoxyfylline is an orally active haemorheological agent for the treatment of peripheral vascular disease, cerebrovascular disease and a number of other conditions involving a defective regional microcirculation. Pentoxyfylline acts primarily by increasing red blood cell deformability, by reducing blood viscosity and by decreasing the potential for platelet aggregation and thrombus formation (mechanism unclear). Pentoxyfylline has also proven to have a significant anti inflammatory effect as well as anti oxidant effect, mechanisms considered to be important patho-physiological causes of contrast induced nephropathy.

NCT ID: NCT01093131 Withdrawn - Clinical trials for Contrast Induced Nephropathy

Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy

HYDRATE
Start date: February 2005
Phase: Phase 4
Study type: Interventional

The increased risk for contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) undergoing coronary angiography (CAG) has been established. Current and historical data on CIN prevention strategies have shown wide variation with respect to the optimal type, route and timing of these therapies. We investigate the role for oral hydration and/or oral sodium bicarbonate administration compared to intravenous hydration and/or sodium bicarbonate in patients with CKD undergoing CAG.

NCT ID: NCT00749827 Withdrawn - Clinical trials for Contrast Induced Nephropathy

Renoprotective Effects of Fluid Prophylaxis Strategies for Contrast Induced Nephropathy (CIN)

CIN
Start date: n/a
Phase: Phase 4
Study type: Interventional

Contrast induced nephropathy (CIN) is a term applied to acute renal failure associated with intravascular injection of iodinated contrast agents typically used for cardiac angiography. CIN occurs in about 15% of those who have had cardiac angiography, with dialysis required by about 0.5% of cases. The development of CIN is associated with other adverse outcomes including major adverse cardiovascular events (MACE) and death. The mechanism underlying the association with MACE and death is unclear and it is largely unknown whether measures reducing the frequency or severity of CIN also reduce these associated adverse events. The cause of CIN in humans is not known, but many preventive therapies have been tested based on our understanding of the mechanism underlying CIN from animal models. Despite multiple studies, no one drug or therapy has been proven to consistently prevent CIN at this time. Prophylactic fluid therapy is uniformly recommended as a component of preventive approaches for CIN. However, the optimal type, dose and duration of fluid therapy remain unclear. Existing studies suggest a role for isotonic saline[3] or bicarbonate[4]. Initial use of hypotonic fluid followed by isotonic fluid might allow a more rapid and sustained increase in tubular fluid flow by suppression of ADH. This should assist in reducing tubular fluid viscosity and the potential for injury by contrast medium. The aim of this research program is to design and test strategies for the prevention of CIN in patients undergoing elective cardiac angiography or percutaneous coronary intervention (PCI). The primary purpose of this pilot study will be to determine the biological plausibility of using a hypotonic solution for CIN prophylaxis. Specific Objectives: Primary 1. To compare the effects of two fluid prophylaxis strategies for CIN on urine output, urine pH, urine composition (urine metabolic profiling), a novel marker of renal injury (NGAL) and urine osmolality Secondary 2. To assess the relative sensitivity of definitions of CIN based on changes in serum creatinine or cystatin C within 72 hours post contrast. 3. To determine the feasibility of a future multicenter randomized trial of a hypotonic fluid prophylaxis strategy for the prevention of radiocontrast nephropathy.