NOT FOR INTRATHECAL USE
Injection USP 60%
Reno-60 is a radiopaque contrast agent supplied as a sterile, aqueous solution for parenteral use.
Reno-60 is indicated in excretion urography (by direct I.V. or drip infusion); cerebral angiography; peripheral arteriography; venography; operative, T-tube, or percutaneous transhepatic cholangiography; splenoportography; arthrography; and discography.
Reno-60 (Diatrizoate Meglumine Injection USP 60%) is also indicated for radiographic contrast enhancement in computed tomography (CT) of the brain and body. Contrast enhancement may be advantageous in delineating or ruling out disease in suspicious areas which may otherwise not have been satisfactorily visualized.
Reno-60 may be useful to demonstrate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas; ependymomas; medulloblastomas; meningiomas; neuromas; pinealomas; pituitary adenomas; craniopharyngiomas; germinomas; and metastatic lesions.
The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated. In cases where lesions have calcified, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement.
Non-Neoplastic Conditions of The Brain
The use of Reno-60 may be beneficial in the enhancement of images of lesions not due to neoplasms. Cerebral infarctions of recent onset may be better visualized with the contrast enhancement, while some infarctions are obscured if a contrast medium is used. The use of Reno-60 (Diatrizoate Meglumine Injection USP 60%) improved the contrast enhancement in approximately 60 percent of cerebral infarctions studied from one week to four weeks from the onset of symptoms.
Sites of active infection also will produce contrast enhancement following contrast medium administration.
Arteriovenous malformations and aneurysms will show contrast enhancement. In the case of these vascular lesions, the enhancement is probably dependent on the iodine content of the circulating blood pool.
Hematomas and intraparenchymal bleeders seldom demonstrate any contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast medium administration may be helpful in ruling out the possibility of associated arteriovenous malformation.
The opacification of the inferior vermis following contrast medium administration has resulted in false-positive diagnoses in a number of normal studies.
Reno-60 (Diatrizoate Meglumine Injection USP 60%) may be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, abdominal cavity, pelvis and retroperitoneal space.
Enhancement of computed tomography with Reno-60 may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions (e.g., hepatic abscess delineation prior to percutaneous drainage). In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (e.g., tumor extension), or may help to define suspicious lesions seen with unenhanced CT (e.g., pancreatic cyst).
Contrast enhancement appears to be greatest within 60-90 seconds after bolus administration of the contrast agent. Therefore, utilization of a continuous scanning technique (“dynamic CT scanning”) may improve enhancement and diagnostic assessment of tumor and other lesions such as an abscess, occasionally revealing unsuspected or more extensive disease. For example, a cyst may be distinguished from a vascularized solid lesion when pre-contrast and enhanced scans are compared; the non-perfused mass shows unchanged X-ray absorption (CT number). A vascularized lesion is characterized by an increase in CT number in the few minutes after a bolus of intravascular contrast agent; it may be malignant, benign or normal tissue, but would probably not be a cyst, hematoma, or other nonvascular lesion.
Because unenhanced scanning may provide adequate diagnostic information in the individual patient, the decision to employ contrast enhancement, which may be associated with risk and increased radiation exposure, should be based upon a careful evaluation of clinical, other radiological, and unenhanced CT findings.
Published Studies Related to Reno-60 (Diatrizoate)
Prospective randomized trial of iohexol 350 versus meglumine sodium diatrizoate as an oral contrast agent for abdominopelvic computed tomography. [2011.03]
CONCLUSION: Iohexol 350 is a satisfactory oral contrast agent for abdominopelvic CT. It opacifies the gastrointestinal tract as well as meglumine sodium diatrizoate does, and patients prefer the taste of iohexol to that of diatrizoate.
Oral contrast media for body CT: Comparison of diatrizoate sodium and iohexol for patient acceptance and bowel opacification. [2010.11]
CONCLUSION: Patents preferred dilute iohexol over dilute diatrizoate sodium for oral contrast for abdominal-pelvic CT. There was no significant difference in bowel opacification or adverse effect profile.
Randomised clinical trial investigating the effects of combined administration of octreotide and methylglucamine diatrizoate in the older persons with adhesive small bowel obstruction. [2006.03]
OBJECTIVE: To investigate the effects of combined administration of octreotide and methylglucamine diatrizoate in the older persons with adhesive small bowel obstruction... CONCLUSIONS: Combined administration of octreotide and methylglucamine diatrizoate accelerates resolution of small bowel obstruction by a specific therapeutic effect and is safe for the older persons.
Preoperative bowel preparation with meglumine and sodium diatrizoate (Gastrografin): a prospective randomised comparison. [2001.12]
OBJECTIVE: To test the use of meglumine and sodium diatrizoate (Gastrografin) as an agent for preoperative mechanical bowel preparation... CONCLUSIONS: Gastrografin can be used successfully as an agent for mechanical bowel preparation before elective colorectal surgery, as it gives equally good cleansing results compared with the established method of whole gut irrigation. It also seems to be better tolerated and accepted by patients.
Effects in vivo of iohexol and diatrizoate on human plasma acetyl- and butyryl-cholinesterase activity. [2001.03]
CONCLUSIONS: Iohexol and diatrizoate induce in vivo a significant decrease of AC and BC plasma activities. The decrease is more pronounced for iohexol, a non ionic CA, which has a lower pharmacotoxicity than diatrizoate and adverse effects rate. No inference can be drawn about the relationship between plasma cholinesterase activity and adverse effects.
Clinical Trials Related to Reno-60 (Diatrizoate)
Intra-Renal Therapy of Diuretic Unresponsive Acute Kidney Injury [Not yet recruiting]
Randomized prospective trial of patients with diuretic unresponsive acute kidney injury
where patients will receive standard supportive therapy with diuretics versus intra-renal
delivery of the vasodilator fenoldopam mesylate.
Patients with rising creatinine who fail to respond to bolus diuretics will be treated with
a prolonged course of diuretics or undergo placement of a catheter within the renal arteries
that allows for infusion of fenoldopam mesylate. The rational is that early delivery of a
high dose vasodilator may reverse the decline of renal function in patients with severe
acute kidney injury.
Rituximab in Kidney Transplantation [Recruiting]
The purpose of this study is to determine whether treatment with rituximab in people who
develop new anti-HLA antibodies after kidney transplant will promote longer-term survival of
the transplanted kidney.
Efficacy Study of Everolimus on Renal Function in Heart Transplant Recipients With Established Chronic Renal Failure [Recruiting]
After transplantation, renal impairment, incidence and progression of atherosclerosis lead
to modification of immunosuppressive regimens, as switch, reduction or discontinuation of
CNI and/or introduction of everolimus. The risk or benefits of these strategies were not
clearly evaluated by specific clinical trials.
This study is specifically designed for evaluating the impact of everolimus introduction,
with calcineurin dose reduction, at less one year after cardiac transplantation, on renal
and clinical outcomes, specially on :
- Renal function improvement
- Vasculopathy and major cardiac event reduction
- Maintenance of immunosuppressive efficacy
A Safety Study of LBH589 (Panobinostat) and RAD001 (Everolimus) to Stabilize Kidney Cancer [Recruiting]
This study will see how these two commonly used treatments (Everolimus and Panobinostat)
work together in treating kidney cancer. These two drugs have already progressed through the
earliest types of research trials, such as a dose finding trial. We will combine these drugs
at doses that were found to be safe when given alone, and will watch participants carefully
to determine how well this drug combination is working to control your kidney cancer.
Effects of HIgh Volume COntinuous REnal Replacement Therapy in Patients With Septic Acute Kidney Injury [Not yet recruiting]
Acute kidney injury (AKI) is a common and serious problem in critically ill patients, and is
known to be an independent risk factor for mortality. Among the various etiologies of AKI,
sepsis or septic shock is the most frequent contributing factor especially in an intensive
care unit setting. Also, the mortality of septic AKI in these patients still remains
extremely high despite recent marked therapeutic advance.
Given the physiologic superiority of continuous renal replacement therapy (CRRT) on uremia
and volume control, it has become the modality of choice in critically ill patients with
AKI. In addition, CRRT can theoretically provide immunohomeostasis through the convective
and adsorptive removal of various immune mediators. Although the pathophysiology of septic
AKI remains elusive, it has become increasingly recognized that many pro- and
anti-inflammatory mediators, such as TNF, IL-6, IL-8 and IL-10, play an important role in
this process. Therefore, it has been speculated that the reduction of cytokines by
increasing CRRT dose in patients with septic AKI may reduce mortality risk. Even though
recent two large scale randomized controlled trials, ATN and RENAL study, have failed to
show the difference in survival rate between the clearance of 20~25 ml/kg/hr and 35~40
ml/kg/hr, none of these studies were designed to elucidate the survival benefit of high
intensity CRRT in patients with septic AKI. Moreover, the optimal target CRRT dose in these
patients is not well established and may be even higher than 35~40 ml/kg/hr in terms of
septic AKI. Indeed, recent several uncontrolled trial have shown the survival benefit of
high intensity CRRT in these patients.
To further explore the effects of high dose CRRT on survival of critically ill patients with
septic AKI, the investigators will conduct a multicenter prospective randomized controlled
open-label trial which compares the difference in survival rate between 1: 1 balanced
pre-dilution CVVHDF at 80 vs. 40 mL/Kg/hr for initial 72hrs after the start of CRRT. The
primary end-point of this study is the effect of high volume pre-dilution CVVHDF on 28-day
survival rate. The secondary end-point is 60- and 90-day mortality, ICU and in-hospital
mortality, duration of CRRT and renal replacement therapy, duration of mechanical
ventilation, cytokine removal rate at 12h after the initiation of CRRT, and changes in SOFA
and APACHE II score at 72h after the initiation of CRRT. This is a superiority trial which
aims to demonstrate a reduction of 20% or more in mortality rate. For this purpose, at least
109 subjects (a total of 218) would be required for each group if type I error rate is 5%
and type II error is 20% given 25% of drop-out rate during the study period. Block
randomization will be used by means of a dedicated website.
There are still conflicting data on the optimal target dose of CRRT in patients with septic
AKI. Our study will address this issue to answer the unresolved question on the effect of
high dose CRRT.
Page last updated: 2011-12-09