Role of diastolic dysfunction in the pathogenesis of dialytic associated hypotension and effect of systematic colloid infusion in refractory cases

ISRCTN	ISRCTN20957055
DOI	https://doi.org/10.1186/ISRCTN20957055
Protocol serial number	AFSSAPS n° 021059
Sponsor	Association Quincy Recherche Clinique et Therapeutique (QRCT) (France)
Funder	Physicians Association of Claude Galien Hospital (Association Quincy Recherche Clinique et Thérapeutique - QRCT) (France)

Submission date: 31/03/2011
Registration date: 18/05/2011
Last edited: 07/12/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Guy Rostoker
Scientific

Service de Néphrologie et de Dialyse
Hopital Privé Claude Galien
2 Rue de Boussy
Quincy sous Senart
91480
France

Phone	+33 (0)1 69 39 92 01
Email	rostotom@orange.fr

Study information

Primary study design	Interventional
Study design	Prospective cross-sectional cohort and prospective crossover study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	Determining of the role of left ventricular diastolic dysfunction and diastolic heart failure in the pathogenesis of dialytic associated hypotension and studying the benefit of routine colloid infusion in hypotension prone dialysis patients (with diastolic dysfunction), who are unresponsive to preventive measures
Study objectives	The increasing number of elderly and diabetic patients and patients with cardiovascular disease may play a pivotal role in the pathogenesis of dialysis associated hypotension through left ventricular diastolic dysfunction and diastolic heart failure. The aim of this pilot study was to assess the potential benefit of systematic infusion of colloids during dialysis in hypotension prone patients who have diastolic dysfunction and are unresponsive to the usual preventive measures
Ethics approval(s)	This trial received approval n°02-017 from the ethics committee of Henri Mondor University Hospital and was registered at the French Agency for Drugs and Health Devices AFSSAPS (n° 021059). 12/06/2002
Health condition(s) or problem(s) studied	End stage renal failure/hemodialysis patients/hemodynamic instability during dialysis sessions
Intervention	1. Cross-sectionnal study of hemodialysis patients: Echocardiography performed 2 hours after a dialysis session and BNP measured at the beginning of mid week dialysis session 2. Cross-over single blind study (lasting 20 weeks) of systematic infusion of 200 ml of albumine 20% and gelatine 4% during 5 weeks each separated by a washout period (lasting 5 weeks)
Intervention type	Other
Primary outcome measure(s)	1. Cross-sectionnal study of hemodialysis patients: E/A ratio, Color M-mode diastolic flow propagation velocity (Vp) 2. Cross-over study of systematic infusion of colloids: arterial pressure regulation, i.e. Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, and the number of hypotensive episodes (defined as SBP < 100 mmHg, regardless of symptoms)
Key secondary outcome measure(s)	1. Cross-sectional study of hemodialysis patients :B-type natriuretic peptide (BNP), Cardiac index, Left-ventricular ejection fraction, Myocardial fractional shortening, Left ventricular mass index 2. Cross-over study of systematic infusion of colloids: nutritional status, ultrafiltration rate, dialysis quality microinflammatory status, oxidative stress, serum nitrate and nitrite levels
Completion date	30/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	116
Key inclusion criteria	1. Hemodialysis patients 2. Age > 16 years and < 90 years 3. Dialysis vintage <10 years 4. Treated by intermittent bipuncture bicarbonate hemodialysis 3 times per week 5. Dialysis hypotension-prone patients identified in the prospective cross-sectionnal study who were unresponsive to preventive measures
Key exclusion criteria	1. Left-ventricular ejection fraction < 40% 2. Malnutrition, anemia unresponsive to erythropoesis stimulating agents requiring transfusions, cancer or severe infection, inadequate dry weight assessed by echocardiography and echography of the vena cava inferior
Date of first enrolment	01/01/2003
Date of final enrolment	30/06/2008

Locations

Countries of recruitment

France

Study participating centre

Service de Néphrologie et de Dialyse

Quincy sous Senart
91480
France

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2009		Yes	No
Results article	results	01/03/2011		Yes	No
Results article	results	20/10/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes