Laboratory parameters in the elderly

ISRCTN	ISRCTN53778569
DOI	https://doi.org/10.1186/ISRCTN53778569
Secondary identifying numbers	N/A

Submission date: 23/05/2015
Registration date: 27/05/2015
Last edited: 18/05/2023

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Laboratory tests are essential to diagnose issues and make treatment decisions. Interpretation of individual results relies on accurate reference intervals and decision limits. A lot of resources are spent on elderly patients but we know very little about accurate reference intervals. The SENIORLAB study aims to address this gap of knowledge by investigating a large variety of laboratory parameters in clinical chemistry, haematology and immunology.

Who can participate?
Senior individuals aged 60 or above, residing in Switzerland and describing themselves as healthy.

What does the study involve?
This is an observational study which involves a visit to the study centre. There will be basic measurements (blood pressure, weight and height) and a fasting blood test. Then participants will be periodically contacted every 3 to 5 years to evaluate their health status.

What are the possible benefits and risks of participating?
Participants receive a selection of results from laboratory tests relevant for healthy seniors (such as glucose, HbA1c, and creatinine). The risk of participation can be considered to be very low and relates to the risk of phlebotomy of a peripheral vein, usually in the cubital region.

Where is the study run from?
Labormedizinisches Zentrum Dr. Risch in Liebefeld (Switzerland)

When is the study starting and how long is it expected to run for?
January 2007 to December 2025

Who is funding the study?
INOVA Foundation (Liechtenstein)

Who is the main contact?
1. Dr Martin Risch (martin.risch@ksgr.ch)
2. Dr Lorenz Risch (lorenz.risch@risch.ch)

Study website

Contact information

Dr Martin Risch
Scientific

Kantonsspital Graubünden
Zentrallabor
Loësstrasse 170
Chur
7000
Switzerland

Dr Lorenz Risch
Public

Labormedizinisches Zentrum Dr. Risch
Waldeggstrasse 37
Liebefeld
3097
Switzerland

ORCID ID	0000-0003-2692-6699

Study information

Study design	Single-center observational trial
Primary study design	Observational
Secondary study design	Epidemiological study
Study setting(s)	Community
Study type	Quality of life
Participant information sheet	http://seniorlabor.ch/index.php?TPL=10062
Scientific title	SENIORLAB: a prospective observational study investigating laboratory parameters and their reference intervals in the elderly
Study acronym	SENIORLAB
Study objectives	In clinical practice, laboratory results are very often important when it comes to make diagnostic, therapeutic and prognostic decisions. Interpretation of individual results relies on accurate reference intervals and decision limits. Despite a considerable amount of resources in clinical medicine spent on elderly patients, accurate reference intervals for the elderly are only rarely available. The SENIORLAB study was set out to address this gap of knowledge determining reference intervals in the elderly by investigating a large variety of laboratory parameters in clinical chemistry, hematology, and immunology.
Ethics approval(s)	Ethics Committee Bern (Kantonale Ethikkommission Bern; KEK), 05/01/2009 & 29/07/2013 (amendment), ref: 166/08
Health condition(s) or problem(s) studied	Subjectively healthy elderly persons aged 60 and over
Intervention	An extensive baseline evaluation is undertaken in the study participants. The participants are followed up for quality of life, morbidity and mortality.
Intervention type	Other
Primary outcome measure	Evaluation of robust reference intervals
Secondary outcome measures	1. Associations between different parameters 2. Diagnostic characteristics of parameters to diagnose different circumstances 3. Prevalence of occult disease in subjectively healthy individuals 4. Risk factors for outcomes
Overall study start date	01/01/2007
Completion date	31/12/2025

Eligibility

Participant type(s)	Healthy volunteer
Age group	Senior
Sex	Both
Target number of participants	1500
Key inclusion criteria	1. Aged 60 or older 2. Resident in Switzerland 3. Subjective perception of being healthy 4. Fasting state when going for baseline examination
Key exclusion criteria	1. Known diabetes mellitus 2. Known thyroid disease 3. Current glucocorticoid use 4. Active neoplastic disease during the past 5 years 5. Consumption of more than 5 pharmacologically active substances (polypharmacy) 6. Hospitalisation during the past 4 weeks
Date of first enrolment	28/05/2009
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Switzerland

Study participating centre

Labormedizinisches Zentrum Dr. Risch

Waldeggstrasse 37
Liebefeld
3097
Switzerland

Sponsor information

Labormedizinisches Zentrum Dr. Risch
Hospital/treatment centre

Waldeggstrasse 37
Liebefeld
3097
Switzerland

"ROR"	https://ror.org/030f5x630

Funders

Funder type

Research organisation

INOVA Research Foundation (Forschungs- und Förderstiftung INOVA) Principality of Liechtenstein

No information available

Results and Publications

Intention to publish date	31/12/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Study results are disseminated as original reports in peer-reviewed scientific journals, systematic reviews, as well as contributions to scientific meetings, as follows: 1. Publications of cross-sectional analyses are ongoing since 2012 2. The method paper of the prospective study will be submitted in June 2015 3. Publication of reference intervals will be continuously submitted starting from the second half 2015 4. Longitudinal analyses will be continuously published beginning 2017
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/01/2017		Yes	No
Results article	results	15/05/2018		Yes	No
Results article	8 year follow up	17/05/2023	18/05/2023	Yes	No

Editorial Notes

18/05/2023: Publication reference added.
17/05/2018: Publication reference added.
11/01/2017: Publication reference added.