Internal Medicine

Clinical trials for Internal Medicine specialty

  • Description

    To evaluate the effect of plavix dosing in respect to how much time is needed to achieve maximum platelet inhibition which may decrease risk of thrombeombolic disease.

    Inclusion Criteria

    Diagnosis of protein losing nephropathy, cases with high indices of suspicion without definitive diagnosis will also be considered.

    Exclusion Criteria

    Dogs will be excluded if they have received steroids or any anticoagulant medications.

    Client Benefits

    May be able to use a lower dose of plavix, therefore, more cost-effective.

    Contact Information

    Dr. Melissa Bucknoff, DVM
    Phonoe: (508) 839-5395

  • Description

    To investigate and identify occult coagulation disorders in cats with cholestatic liver disease before any procedures (FNA, biopsy, surgery, e-tube placement).

    Inclusion Criteria

    serum bilirubin >/= 3, ALT/ALP > 2x upper limit of reference range.

    Exclusion Criteria

    PCV < 28%, obvious neoplasia, heart disease, icterus due to sepsis or hemolysis, meds (NSAIDs, steroids, fatty acids).

    Client Benefits

    PT/PTT, plt count, pcv/ts, and TEG

    Contact Information

    Gideon.Daniel@tufts.edu

  • Description:

    A common concurrent condition often appreciated in feline CKD patients is cardiac disease. High rate fluid therapy to treat azotemia puts these patients at risk for congestive heart failure( CHF). Anecdotally at Tufts, an improvement in azotemia, appetite and attitude has been noted in cats treated for cardiac disease with pimobendan that also have kidney disease. We would like to assess tolerability of pimobendan and possible benefits in patients with CKD, IRIS stage 3 or 4. Investigating these initial clinical observations with a larger study will help establish whether pimobendan could be a novel treatment for cats with kidney disease. Benefits could include decreased hospitalization time, improved appetite, improved kidney perfusion with reduced azotemia, and the ability to treat kidney disease while simultaneously protecting against CHF in patients with concurrent cardiac disease.

    Inclusion Criteria:

    Cats with IRIS stage 3 or 4 CKD at the time of hospital admission will be included in this study. After 24 to 72 hours of fluids, once dehydration is judged to be largely resolved (<5% dehydrated), cats would be eligible to enter one of two groups receiving the standard of care and either benazepril or pimobendan.

    Cats with concurrent cardiac disease that are not currently receiving cardiac medications and are not experiencing signs of CHF at presentation, including respiratory distress or oxygen dependence, will be allowed to participate in this study.

    Exclusion Criteria:

    Cats with comorbid conditions (i.e. diabetes mellitus, liver failure, neoplasia, ureteral obstruction, and acute kidney injury that requires dialysis), those unwilling to take oral medication (i.e. vomiting, fractious), and cats with hypotension (blood pressure <120 mmHg) will be excluded from this study.

    Any cats experiencing unusual agitation, anorexia, vomiting >2 times, worsening of low blood pressure (<120mmHg), worsening of existing cardiac disease, diagnostic evidence of progression of kidney disease (increased BUN/creatinine), or side effects that adversely affect quality of life after starting the study drug will be removed from this study.

    Client Benefits:

    The study will cover some of the costs of CKD care, including one set of recheck blood work, blood pressure, urine evaluation, and cardiac evaluation using echocardiographic technique at no additional charge. Your animal will not be subjected to additional diagnostic tests than is standard for monitoring CKD patients. All other costs for treatment of CKD will be incurred by you. Your pet’s participation will also allow us to gain information which will help in treatment of other cats with this condition.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

  • Description:

    Canine borreliosis has been associated with renal failure and death (“Lyme nephritis’) although causation remains speculative. The Ixodes tick in Northeastern U.S. transmits Borrelia burgdorferi, Anaplasma phagocytophilum, and Babesia microti. Babesia microti-like organisms have been associated with anemia, renal failure, and death in dogs in Spain. Babesia microti is known to infect humans and foxes in the Northeastern United States.  We intend to investigate the incidence of babesial infection in dogs with signs suggestive of Lyme nephritis.  We hypothesize that renal failure and death attributed to borrelial infection in dogs (“Lyme nephritis’) is due to infection or co-infection with a Babesia microti-like organism.

    As a control group, we will be obtaining blood samples from dogs presenting to Tufts Foster Hospital for Small Animals for surgical repair of cruciate ligament disease for the presence of Babesia microti-like DNA.

    Inclusion Criteria:                                           

    Control dogs: Healthy dogs presenting for surgical repair of cruciate ligament disease.

    Client Benefits:

    The study will cover the costs of blood testing for Babesia microti-like infection, heartworm disease and exposure to the infectious organisms Ehrlichia canis, Anaplasma phagocytophilum and Borrelia burgdorferi. Your pet’s participation will also allow us to gain information which will help in the diagnosis and management of other patients.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

  • Enrollment beginning in January 2015

    Description:

    The purpose of the study is to determine whether the administration of canine umbilical cord derived mesenchymal stem cells (UC-MSCs) is safe, and if it will reduce kidney injury to a greater extent than the current standard of care. The study will measure kidney values to see if they stay in or return to a normal range as well as overall survival. Secondarily, the study will monitor for any changes in your dog’s likelihood to form blood clots.

    Inclusion Criteria:

    Dogs presenting with protein-losing nephropathy, hypoalbuminemia (<2.0 g/dl), azotemia (creatinine >2.0), thrombocytopenia (platelets < 160,000), and a hypercoaguable state.

    Any gender, and any breed, weighing > 4 kg (8.8 pounds).

    Able to come back for recheck appointments on days 2, 7, 14, 30 and 3, 6 and 12 months post injection.

    Exclusion Criteria:

    Dogs weighing less than 4 kg (8.8 pounds)

    Dogs not expected to live greater than 48 hours, those with cardiac disease, and those with neoplasia.

    Also excluded will be those dogs with an active bacterial urinary tract infection, and those suspected or confirmed to have leptospirosis.

    Client Benefits:

    The study will cover some of the costs that are typically acrued in the diagnostic evaluation of dogs with protein-losing kidney disease including complete blood count, chemistry profile, urinalysis, urine culture, urine protein creatinine ratio, thromboeslatograph (a clotting profile), antithrombin level (to see if your dog is at risk for forming blood clots), ANA (looking for lupus, an autoimmune disease) , serology for tick borne diseases and leptospirosis. It will also cover an abdominal ultrasound examination and the cost of a kidney biopsy. Kidney biopsy is part of the standard diagnostic workup for dogs with protein-losing kidney disease permits it (not too anemic, platelet count adequate, and not hypertensive). The risks associated with kidney biopsy are blood loss from the biopsy site. Your dog will be monitored closely for 4 hours after the biopsy to make sure that any bleeding stabilizes. Heart rate, respiratory rate, mucus membrane color, and blood count will be monitored hourly. Should there be any evidence of sustained bleeding, your dog will be administered intravenous fluids and if needed a blood transfusion. The cost of the blood transfusion will be the responsibility of the owner. The study will also cover the cost for follow up blood work at the scheduled rechecks during the 365 days of the study. Your pet’s participation will also allow us to gain information which will help in the diagnosis/management/treatment of other dogs with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

  • Use of allogeneic canine umbilical cord mesenchymal stem cells for the treatment of inflammatory bowel disease and concurrent protein losing enteropathy in dogs: effect on clinical scoring and serum protein levels

    Enrollment beginning January 2015

    Description:

    Dogs get a disease of the intestine called inflammatory bowel disease (IBD) in which the normal lining of the intestine is replaced by inflammatory white blood cells. This inflammation results in poor digestion,  often manifesting as diarrhea, vomiting, and weight loss, and in some cases, loss of protein through the feces. This leads to a severe protein deficiency in the body, called a protein losing enteropathy (PLE). PLE is typically an indication of very severe intestinal inflammation and dogs with this condition may not respond well to typical medications used to treat IBD. In addition the PLE itself can cause fatal complications such as edema, fluid in the abdominal cavity, and blood clots. There is a need for new therapies to treat dog with PLE secondary to IBD. Based on evidence in the literature from pre-clinical and clinical trials in humans, we hypothesize that treatment of dogs with a PLE from IBD with stem cells isolated from the umbilical cords of dogs will modulate the inflammatory response in the intestine and induce clinical remission.

    The purpose of the study is to determine whether intravenous administration of cells called mesenchymal stem cells can improve your dog’s clinical signs as well as their blood protein levels. It is believed that the benefit of these stem cells is related to their ability to suppress inflammation.

    Inclusion Criteria:

    Dogs will have had incomplete response to therapy with prednisone, budesonide and/or cyclosporine (defined by a clinical score (CCECAI) >5), have intolerable side effects on medication, or have the administration of cyclosporine or chlorambucil be financially unreasonable for the owner, as these are the patients who require alternative therapeutic options.

    Dogs with biopsy confirmed IBD and bloodwork confirmed panhypoproteinemia

    (total protein <5.5 mg/dl) will be enrolled. The biopsies may be performed at Tufts if they are not already available for pathologist review.

    Both male and female dogs weighing greater than 11 pounds and any age will be considered for the study.

    Exclusion Criteria:

    Dogs with a urine protein:creatinine (UPC) ratio of >0.5, a baseline cortisol < 2 ug/dL, and a post- prandial bile acids of > 30 uM will be excluded from the study. This will eliminate dogs with protein loss through the kidneys, abnormal production of protein from the liver, or Addison’s disease. These tests can be performed at Tufts.

    All dogs will have an abdominal ultrasound and those with signs of intestinal or extra-intestinal masses will be excluded.

    Yorkshire Terriers, Soft-Coated Wheaten Terriers, and Boxers will be excluded, as these dogs have unique IBD features that respond differently from the general population of dogs.

    Dogs with congestive heart failure, Cushing’s disease, diabetes mellitus, or cancer will also be excluded.

    Client Benefits:

    Expenses associated with giving the injection of stem cells and in evaluating your dog after the injection will be covered. Some initial testing, recheck examinations, and follow-up blood work will be covered. Your pet’s participation will also allow us to gain valuable information which will help in the management and treatment of other dogs with this condition.

     

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

     

  • Description:

    The liver performs an essential role in absorption of dietary vitamin D and synthesis of the active form of vitamin D. Vitamin D deficiency is a known problem in people with liver disease and these patients routinely receive supplementation.  Vitamin D deficiency has not been documented in cats with liver disease.  Our goal is to determine if cats with primary liver disease have low levels of vitamin D.  If they do this finding could lead to the development of clinical guidelines for vitamin D supplementation.

     Inclusion Criteria:

    Cats over 1 year of age with one of the following:

    • Hyperbilirubinemia
    • Elevated ALT and/or ALP
    • Cytologic or histopathologic diagnosis of a primary hepatobiliary disease

    Exclusion Criteria:

    • Hyperthyroidism
    • Acute pancreatitis
    • IRIS Stage 2 chronic kidney disease (creatinine >1.6 mg/dl)
    • Congestive heart failure
    • Hypercalcemia (elevated ionized calcium)
    • Corticosteroid or ursodeoxcholic acid administration within the last 2 weeks

     

    Client Benefits:

    The study will cover the cost of the vitamin D panel. Your cat’s participation will also allow us to gain information which will help in the treatment of other cats with this condition

    Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu