Addison Disease Clinical Trial
Official title:
Prospective Evaluation of Adrenal Function After Living Donor Nephrectomy With or Without Ligation of the Adrenal Vein
Verified date | December 2016 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Observational |
The success of kidney transplantation is hampered by the shortage of organs. One attractive
strategy is the use of kidneys from living donors. During the donor operation the kidney
artery, kidney vein and ureter have to be interrupted as far as possible from the kidney to
have sufficient length for the reconnection of these structures in the transplant operation.
An adrenal gland is situated at the upper pole of each kidney. While the arterial supply is
accomplished by many small vessels, the venous drainage is only through one vein. On the
right side the adrenal vein empties directly into the inferior vena cava (the large vessel
transporting blood from the lower body to the heart). In contrast, on the left side the
adrenal vein empties into the kidney vein, which in turn drains to the inferior vana cava.
Due to these anatomical differences a left-sided removal of a kidney always necessitates an
interruption of the left adrenal vein, while a right-sided kidney removal does not.
As the venous drainage of the left adrenal gland is closed during living kidney donation,
the gland is most likely functionally impaired. This can be compared to a right-sided kidney
donation, where the adrenal vein is left intact. These comparisons are performed by adrenal
function tests before, one week after and one month after kidney donation. These function
tests consist of blood values drawn after stimulation with a hormone drug.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Eligible kidney donor (meeting institutional selection criteria) - Informed consent for study participation Exclusion Criteria: - Treatment with glucocorticoids - Preexisting diseases of adrenal function (hypercortisolism, hyperaldosteronism, adrenal insufficiency) - Inability to undergo MRI examination (metal implants, etc.) - Inability to understand the study information and to give informed consent (in German) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Switzerland | Dept. of Visceral and Transplantation Surgery, University Hospital Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | Ludwig-Maximilians - University of Munich |
Switzerland,
Bischoff P, Noldus J, Harksen J, Bause HW. [The necessity for perioperative cortisol substitution. Spontaneous and stimulated ACTH and cortisol secretion during unilateral adrenalectomy for renal cell carcinoma]. Anaesthesist. 1997 Apr;46(4):303-8. German. — View Citation
Cassinello Ogea C, Girón Nombiela JA, Ruiz Tramazaygues J, Izquierdo Villarroya B, Sánchez Tirado JA, Almajano Domínguez RM, Oro Fraile J. [Severe perioperative hypotension after nephrectomy with adrenalectomy]. Rev Esp Anestesiol Reanim. 2002 Apr;49(4):213-7. Spanish. — View Citation
Hariharan S, Johnson CP, Bresnahan BA, Taranto SE, McIntosh MJ, Stablein D. Improved graft survival after renal transplantation in the United States, 1988 to 1996. N Engl J Med. 2000 Mar 2;342(9):605-12. — View Citation
Henrich WL, Goldberg J, Lucas M, Gabow P. Adrenal insufficiency after unilateral radical nephrectomy. Urology. 1976 Dec;8(6):584-5. — View Citation
Messiant F, Duverger D, Verheyde I, Declerck N, Pruvot FR, Scherpereel P. [Postoperative acute adrenal insufficiency]. Ann Fr Anesth Reanim. 1993;12(6):594-7. French. — View Citation
Safir MH, Smith N, Hansen L, Kozlowski JM. Acute adrenal insufficiency following unilateral radical nephrectomy: a case report. Geriatr Nephrol Urol. 1998;8(2):101-2. — View Citation
Sèbe P, Peyromaure M, Raynaud A, Delmas V. Anatomical variations in the drainage of the principal adrenal veins: the results of 88 venograms. Surg Radiol Anat. 2002 Aug-Sep;24(3-4):222-5. — View Citation
Yokoyama H, Tanaka M. Incidence of adrenal involvement and assessing adrenal function in patients with renal cell carcinoma: is ipsilateral adrenalectomy indispensable during radical nephrectomy? BJU Int. 2005 Mar;95(4):526-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma cortisol response to low-dose ACTH stimulation | Low-dose ACTH1-24 stimulation test was conducted by drawing blood at 8 am, then injecting 1 Ig of Synacthen intravenously and drawing further blood samples after 30, 60, and 90 minutes | Pre-operative, day 1 and day 28 after kidney donation | No |
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