Trial record 6 of 6 for:    Open Studies | "Addison's Disease"

Adrenal Function After Living Kidney Donation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00251836
First received: November 8, 2005
Last updated: April 17, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention
Addison Disease
Hypoaldosteronism
Procedure: Laparoscopic hand-assisted donor nephrectomy

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Prospective Evaluation of Adrenal Function After Living Donor Nephrectomy With or Without Ligation of the Adrenal Vein

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Estimated Enrollment: 30
Study Start Date: December 2005
Estimated Study Completion Date: December 2007
Detailed Description:

Due the lack of suitable donor organs a large proportion of kidney transplantations is now performed from living donors. In the year 2002 the number of living donors surpassed the number of cadaveric donors in Switzerland (Swisstransplant, Swiss Transplant Society 2005). Kidney grafts from living donors have superior long-term outcome (Hariharan S, N Engl J Med 2000). At the University Hospital Zurich 28 of the 84 kidney transplantations performed in the year 2004 were from living donors.

During living donor nephrectomy the renal artery and renal vein are transected as far away from the kidney as possible, to ensure an adequate vessel length for the subsequent transplantation procedure. The arterial supply of the adrenal glands is accomplished by several small vessels (ca. 5-15), while the venous drainage is usually dependent on a single vein. While the right-sided adrenal vein drains directly into the inferior vena cava (IVC), the left-sided adrenal vein drains into the renal vein. Variants are relatively rare and occur in 5% of cases (Sebe P, Surg Radiol Anat 2002). Therefore, during donor nephrectomy of the left kidney the adrenal vein is transected, while this is not necessary on the right side.

The question addressed in this clinical trial is whether left-sided donor nephrectomy affects the left adrenal gland. This might be compensated immediately by the contralateral gland or it might lead to a measurable functional adrenal deficit. Such an adrenal insufficiency could be detrimental to the immediate postoperative course. The intermediate-term outcome of the adrenal glands is also of interest, as an impairment of the left adrenal gland will lead to a hypertrophy of the contralateral gland.

Few scientific publications have addressed these questions. There are case reports of acute intra- and postoperative adrenal insufficiency in patients undergoing nephrectomy with adrenalectomy (Cassinello Ogea C, Rev Esp Anestesiol Reanim 2002, Henrich WL, Urology 1976, Messiant F, Ann Fr Anesth Reanim 1993, Safir MH, Geriatr Nephrol Urol 1998). A small prospective study in patients undergoing radical nephrectomy (including adrenalectomy) did not find signs of adrenal insufficiency (Bischoff P, Anaesthesist 1997). However a subgroup analysis of a newer study demonstrated adrenal insufficiency in radical versus adrenal-sparing nephrectomy (Yokoyama H, BJU Int 2005).

The study hypothesis is that left-sided donor nephrectomy (i.e. with transaction of the adrenal vein) is deleterious to the left adrenal gland and causes a measurable transient adrenal insufficiency after the operation. The primary study endpoint is the assessment of adrenal function after donor nephrectomy. This is done by an ACTH stimulation test, performed at baseline, in the first week after the operation and 4 weeks after the operation. Comparisons are performed between baseline and postoperative values, as well as between left-sided kidney donors (n=20) and right-sided kidney donors (n=10). A secondary study endpoint is to assess the morphological response of both adrenal glands after donor nephrectomy. To this end MRI and volumetry of the adrenal glands is performed at the same time points, with the hypothesis that left-sided nephrectomy will lead to an involution of the left adrenal followed by hypertrophy of the right adrenal.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251836

Contacts
Contact: Antonio Nocito, MD +41 44 255 ext 1111 antonio.nocito@usz.ch
Contact: Cornelia Ortlieb, RN +41 44 255 ext 8796 cornelia.ortlieb@usz.ch

Locations
Switzerland
Dept. of Visceral and Transplantation Surgery, University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Markus Weber, MD    +41 44 255 ext 3300    markus.weber@usz.ch   
Contact: Antonio Nocito, MD    +41 44 255 ext 11 11    antonio.nocito@usz.ch   
Principal Investigator: Markus Weber, MD         
Sub-Investigator: Felix Dahm, MD         
Sub-Investigator: Antonio Nocito, MD         
Sponsors and Collaborators
University of Zurich
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Markus Weber, MD Dept. of Visceral and Transplantation Surgery, University Hospital Zurich
  More Information

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00251836     History of Changes
Other Study ID Numbers: StV 34-2005, RAB-F-02-0046
Study First Received: November 8, 2005
Last Updated: April 17, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Kidney donation
Organ Donation
Vascular anatomy
Adrenal Insufficiency

Additional relevant MeSH terms:
Addison Disease
Hypoaldosteronism
Adrenal Gland Diseases
Adrenal Insufficiency
Autoimmune Diseases
Endocrine System Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 21, 2014