NCT01015755

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
353

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2010

Typical duration for early_phase_1

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 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

2.5 years

First QC Date

November 17, 2009

Last Update Submit

March 7, 2013

Conditions

Thirst

Keywords

thirst palliation and intensive care unitthirst intensity and distresspredictors of thirst

Outcome Measures

Primary Outcomes (1)

  • Thirst intensity

    after thirst intervention

Secondary Outcomes (1)

  • Thirst distress

    after thirst intervention

Study Arms (1)

thirst intervention

EXPERIMENTAL
Behavioral: combined therapy treatment

Interventions

combined therapy treatmentBEHAVIORAL

mouth care

thirst intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • unable to self-report thirst
  • comatose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143-0610, United States

Location

Related Publications (1)

  • Puntillo K, Arai SR, Cooper BA, Stotts NA, Nelson JE. A randomized clinical trial of an intervention to relieve thirst and dry mouth in intensive care unit patients. Intensive Care Med. 2014 Sep;40(9):1295-302. doi: 10.1007/s00134-014-3339-z. Epub 2014 Jun 4.

    PMID: 24894026DERIVED

Study Officials

  • Kathleen A Puntillo, RN, DNSc

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nursing, Emeritus

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

January 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 8, 2013

Record last verified: 2013-03

Locations

US(1)