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Adrenal Function After Living Kidney Donation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251836
Recruitment Status : Completed
First Posted : November 10, 2005
Last Update Posted : December 29, 2016
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date November 8, 2005
First Posted Date November 10, 2005
Last Update Posted Date December 29, 2016
Study Start Date January 2007
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 28, 2016)
Plasma cortisol response to low-dose ACTH stimulation [ Time Frame: Pre-operative, day 1 and day 28 after kidney donation ]
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
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Adrenal Function After Living Kidney Donation
Official Title Prospective Evaluation of Adrenal Function After Living Donor Nephrectomy With or Without Ligation of the Adrenal Vein
Brief Summary

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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All eligible living donors were considered for participation in the study unless exclusion criteria were present: active corticoid medication, known adrenal disease such as hypercortisolism, hyperaldosteronism or adrenal insufficiency, or the presence of metallic implants precluding MRI investigation. All living kidney donor candidates underwent a standard somatic and psychological eligibility testing during a brief hospitalization in accordance with the Swiss Transplantation Act and the guidelines of the Swiss Academy of Medical Sciences.
  • Addison Disease
  • Hypoaldosteronism
Intervention Procedure: Laparoscopic hand-assisted donor nephrectomy
Study Groups/Cohorts
  • Left-sided donor nephrectomy
    Left-sided laparoscopic hand-assisted donor nephrectomy
    Intervention: Procedure: Laparoscopic hand-assisted donor nephrectomy
  • Right-sided donor nephrectomy
    Right-sided laparoscopic hand-assisted donor nephrectomy
    Intervention: Procedure: Laparoscopic hand-assisted donor nephrectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 8, 2005)
Original Enrollment Same as current
Actual Study Completion Date April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility 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)
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
Administrative Information
NCT Number NCT00251836
Other Study ID Numbers StV 34-2005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators Ludwig-Maximilians - University of Munich
Principal Investigator: Markus Weber, MD Dept. of Visceral and Transplantation Surgery, University Hospital Zurich
PRS Account University of Zurich
Verification Date December 2016