Oral Water Ingestion in Heart Transplant Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00581321
First received: December 22, 2007
Last updated: January 7, 2013
Last verified: January 2013

December 22, 2007
January 7, 2013
January 2006
December 2013   (final data collection date for primary outcome measure)
change in total vascular resistance [ Time Frame: 40 min (before to 30 min after water ingestion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00581321 on ClinicalTrials.gov Archive Site
  • blood pressure [ Time Frame: 40 min ] [ Designated as safety issue: No ]
  • heart rate [ Time Frame: 40 min ] [ Designated as safety issue: No ]
  • plasma norepinephrine [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Oral Water Ingestion in Heart Transplant Patients
Acute Hemodynamic Effects of Oral Water in a Stable Cardiac Transplant Population

In this study the investigators propose to assess the hemodynamic response to the ingestion of 16 fl oz of water. The investigators will test the hypothesis that water ingestion will increase the systemic vascular resistance.

In this study we propose to assess the hemodynamic response to the ingestion of 16 fl oz of water. We will test the hypothesis that water ingestion will increase the systemic vascular resistance. This study will occur in patients status post cardiac transplantation during their clinical right heart catheterizations. Invasive hemodynamics including cardiac outputs and plasma norepinephrine levels will be measured before and 30 min after the water ingestion.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Blood Pressure
  • Cardiac Transplantation
Dietary Supplement: water
water 500 ml x 1
Experimental: 1
water ingestion
Intervention: Dietary Supplement: water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • s/p cardiac transplantation scheduled for clinical right heart catheterization
  • age > 18 years

Exclusion Criteria:

  • significant tricuspid regurgitation
  • inability to safely swallow 500 ml of water
  • other major medical comorbidities such as advanced renal disease where water ingestion may be harmful to patient
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00581321
050811, 1 UL1 RR024975
No
Satish R. Raj, Vanderbilt University
Satish R. Raj
National Institutes of Health (NIH)
Principal Investigator: Satish R Raj, MD, MSCI Vanderbilt University
Vanderbilt University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP