RENOCAL-76 SUMMARY
RenoCal-76®
Diatrizoate Meglumine and
Diatrizoate Sodium Injection USP
RenoCal-76 (Diatrizoate Meglumine and Diatrizoate Sodium Injection USP) is a radiopaque contrast agent for intravascular use supplied as a sterile, aqueous solution. Each mL provides 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium with 0.1 mg edetate calcium disodium as a sequestering agent. The pH has been adjusted to 6.0-7.7 with sodium carbonate and sodium hydroxide or hydrochloric acid. Each mL contains approximately 3.69 mg (0.16 mEq) sodium and 370 mg of organically bound iodine. The viscosity of the solution is 15 cps at 25°C and 9.1 cps at 37°C. It is hypertonic to blood with an osmolality of 1870 mOsm/kg. At the time of manufacture, the air in the container is replaced by nitrogen.
RenoCal-76 is indicated in excretion urography, nephrotomography, aortography, pediatric angiocardiography, peripheral arteriography, selective renal arteriography, selective visceral arteriography, selective coronary arteriography, selective coronary arteriography combined with left ventriculography, and intravenous digital subtraction angiography (DSA).
Computed Tomography
RenoCal-76 is also indicated for radiographic contrast enhancement in computed tomography (CT) of the brain. Contrast enhancement is advantageous in delineating or ruling out disease in suspicious areas which may otherwise not have been satisfactorily visualized.
Tumors
RenoCal-76 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
The use of RenoCal-76 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 RenoCal-76 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.
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FDA Approvals
Clinical Trials Related to Renocal-76 (Diatrizoic Acid / Diatrizoic Acid Intravascular)
Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery [Recruiting]
The purpose of this trial is to determine whether the water-soluble contrast (gastrografin)
is more effective in the treatment of postoperative ileus than the conventional one.
(Gastrografin Use in Small Bowel Obstruction Caused by Adherences) [Completed]
Adhesive small intestine obstruction (ASIO) is an important cause of hospital admission and a
very common disease. Any improvement in this field will benefit many patients by reducing the
operative rate. Patients with this disease are difficult to evaluate and to manage and their
treatment is controversial. Emergency surgery is mandatory when strangulation is suspected or
in the case of total obstruction. On the other hand, conservative non-operative treatment is
indicated in the case of partial obstruction. The role of water-soluble contrast medium
(Gastrografin®: GG) in ASIO is still debated with regard to the therapeutic value.
The aim of our study was to determine the therapeutic role of Gastrografin in patients with
small intestine obstruction without strangulation caused by adherences (ASIO).
Gastrografin in Postoperative Ileus [Recruiting]
After abdominal surgery there is a period of unavoidable dysfunction of the gut. During this
time patients are often unable to eat and drink, and do not pass any flatus or stool. Though
this resolves within a few days for most, there are a significant number (around 30%) who go
on to have a prolonged period of this dysfunction known clinically as postoperative ileus.
It has been clearly shown that this group of patients have worse health outcomes and spend a
longer time in hospital.
The aim of this study is to trial a drug - gastrografin - in the management of prolonged
postoperative ileus. Gastrografin is safe, economical, readily available, and has been used
with great success in the similar condition of bowel obstruction. It is predicted that
gastrografin will shorten the duration of a prolonged postoperative ileus, thus affording
affected patients a better outcome from surgery.
Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction [Recruiting]
Small bowel obstructions are responsible for 2 to 5% of emergency hospital admissions and
20% of all emergency surgical procedures. In 60 to 80% of cases, acute small bowel
obstructions are the consequence of intraperitoneal postoperative adhesions. They constitute
an extremely frequent pathology, leading to a high rate of hospital admissions and money
expense.
Management of small bowel obstruction is based on 2 options: either a surgical approach
where all patients are operating on, or a conservative treatment in which surgery is
proposed in case of failure of medical treatment. The surgical approach leads to operate on
an excessive rate of patients while the medical approach increases the risk of increased
small bowel resection, morbidity rate or hospitalization duration.
In order to improve the management of small bowel obstruction, it seems necessary to better
distinguish patients that need an emergency surgical procedure from patients in which
medical treatment will be useful. Many studies have been performed to investigate the value
of imaging in the management of small bowel obstruction, using abdominal X-ray, oral
gastrografin administration or CT-Scan.
The aim of this study is to analyse the effect of a systematic performance of imaging
investigation on the management of patients presenting with a postoperative small bowel
obstruction.
All patients suffering from a postoperative small bowel obstruction will be included in this
study. They will be randomised in 2 groups. In group S, patients will have CT-Scan and oral
water administration while in group SG, Patients will have CT-Scan and oral gastrografin
administration The major end point of this study is to analyse whether imaging examination
can reduce the need for a surgical approach or the rate of small bowel resection and to
determine its influence on fasting time or hospitalization duration
Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT [Recruiting]
Patients who are scheduled by their health care provider for routine CT scan will be asked
to participate in this study. The primary purpose is to determine if there is a difference
in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic
CT. A secondary objective is to evaluate if there is significant difference in bowel
opacification for the two agents.
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