NCT00251836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

7.3 years

First QC Date

November 8, 2005

Last Update Submit

December 28, 2016

Conditions

Addison DiseaseHypoaldosteronism

Keywords

Kidney donationOrgan DonationVascular anatomyAdrenal Insufficiency

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Left-sided donor nephrectomy

Left-sided laparoscopic hand-assisted donor nephrectomy

Procedure: Laparoscopic hand-assisted donor nephrectomy

Right-sided donor nephrectomy

Right-sided laparoscopic hand-assisted donor nephrectomy

Procedure: Laparoscopic hand-assisted donor nephrectomy

Interventions

Laparoscopic hand-assisted donor nephrectomyPROCEDURE
Left-sided donor nephrectomyRight-sided donor nephrectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Eligible kidney donor (meeting institutional selection criteria)
  • Informed consent for study participation

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Visceral and Transplantation Surgery, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (8)

  • 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. doi: 10.1056/NEJM200003023420901.

    PMID: 10699159BACKGROUND

  • Sebe 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. doi: 10.1007/s00276-002-0021-x. Epub 2002 Jun 13.

    PMID: 12375078BACKGROUND

  • Cassinello Ogea C, Giron Nombiela JA, Ruiz Tramazaygues J, Izquierdo Villarroya B, Sanchez Tirado JA, Almajano Dominguez RM, Oro Fraile J. [Severe perioperative hypotension after nephrectomy with adrenalectomy]. Rev Esp Anestesiol Reanim. 2002 Apr;49(4):213-7. Spanish.

    PMID: 14606383BACKGROUND

  • Henrich WL, Goldberg J, Lucas M, Gabow P. Adrenal insufficiency after unilateral radical nephrectomy. Urology. 1976 Dec;8(6):584-5. doi: 10.1016/0090-4295(76)90525-2.

    PMID: 997054BACKGROUND

  • 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. doi: 10.1016/s0750-7658(05)80629-x. French.

    PMID: 8017676BACKGROUND

  • 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. doi: 10.1023/a:1008305627588.

    PMID: 9893218BACKGROUND

  • 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. doi: 10.1007/s001010050405. German.

    PMID: 9229984BACKGROUND

  • 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. doi: 10.1111/j.1464-410X.2005.05332.x.

    PMID: 15705073BACKGROUND

MeSH Terms

Conditions

Addison DiseaseHypoaldosteronismAdrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Markus Weber, MD

    Dept. of Visceral and Transplantation Surgery, University Hospital Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2005

First Posted

November 10, 2005

Study Start

January 1, 2007

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 29, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)