Palliation of Thirst in ICU Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathleen Puntillo, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01015755
First received: November 17, 2009
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

Patients in Intensive Care Units are often extremely thirsty due to their medicines, illness, treatments or medicines that they receive. This study will test whether patients who receive a easy to implement intervention for thirst will have greater relief from thirst than a group of patients who do not receive the intervention. The study will also identify the most important factors that make ICU patients thirsty so that future research studies can test how to relieve those factors and/or make interventions for thirst more readily available.


Condition Intervention Phase
Thirst
Behavioral: combined therapy treatment
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Palliation of Thirst in ICU Patients

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Thirst intensity [ Time Frame: after thirst intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Thirst distress [ Time Frame: after thirst intervention ] [ Designated as safety issue: No ]

Enrollment: 353
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: thirst intervention Behavioral: combined therapy treatment
mouth care

Detailed Description:

This study will test the efficacy of an innovative, inexpensive, resource-efficient treatment for thirst -- one of the most pervasive, intense, unrecognized, and under-treated symptoms suffered by critically ill patients in Intensive Care Units (ICUs). The first aim of this single-blinded, randomized clinical trial is to test a non-pharmacologic intervention for thirst in ICU patients. The intervention is a combination therapy treatment (CTT) for thirst that includes the use of sterile water mouth sprays, sterile water swabs, and menthol-based lip and tongue moisturizer. The second aim of the study is to examine demographic, environmental, and health and illness factors that increase an ICU patient's risk profile for thirst. Aim #1 hypotheses: (1) Thirst intensity and distress will decrease significantly in ICU patients who receive a CTT for thirst compared to those who receive research team observation. (2) Subjective (e.g., dry mouth) and objective (e.g., cracked lips) thirst-related characteristics will decrease significantly in ICU patients who receive a CCT for thirst compared to those who receive research team observation. Aim #2 hypotheses: (1) A significant association will be found between presence of thirst and certain risk factors for thirst, e.g., serum osmolality, hydration status, and administration of certain medications, e.g., opioids. (2) A significant association will be found between the intensity of thirst and certain risk factors for thirst, e.g., serum osmolality, hydration status, and administration of certain medications, e.g., opioids.

The sample will be 245 ICU patients in one Experimental and two Control groups. Those with thirst will be randomized to either the Experimental or the Control 1 group. The Experimental group will receive the CTT; the Control 1 group will receive research team observation. The Control 2 group patients who reported no thirst will be compared to the Control 1 group on characteristics associated with the presence and intensity of thirst.

Multilevel linear regression models will be employed to test the difference in the linear change trajectories between the treatment and control groups. Multiple logistic regression analysis and multiple linear regression analysis will be used to determine association of risk factors with the presence and intensity of thirst, respectively.

Results will contribute empirical data needed to stimulate a far overdue nursing practice change for the treatment of thirst in ICUs. Results will also identify a risk profile for thirst that will be an important target for future research of thirst in ICU patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must be able to self-report thirst intensity or distress

Exclusion Criteria:

  • unable to self-report thirst
  • comatose
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015755

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143-0610
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kathleen A Puntillo, RN, DNSc University of California, San Francisco
  More Information

No publications provided

Responsible Party: Kathleen Puntillo, Professor of Nursing, Emeritus, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01015755     History of Changes
Other Study ID Numbers: 1R01NR011825-01
Study First Received: November 17, 2009
Last Updated: March 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
thirst palliation and intensive care unit
thirst intensity and distress
predictors of thirst

ClinicalTrials.gov processed this record on April 17, 2014