NCT01945944

Brief Summary

Children who need to be on a ventilator often have thick secretions/mucus in their lungs. These secretions can obstruct the breathing tube and their windpipe, which can worsen lung function and prolong the need for the ventilator. Hypertonic saline is a medicine that is used to thin out secretions in patients with cystic fibrosis (and other conditions). We hypothesize that having children on a ventilator inhale this medication will shorten the amount of time that they need to be on the ventilator.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2013

Shorter than P25 for 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

September 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 28, 2016

Completed
Last Updated

June 28, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

September 12, 2013

Results QC Date

July 27, 2015

Last Update Submit

May 19, 2016

Conditions

Respiratory Failure

Keywords

pediatricmucolyticrespiratory failureatelectasishypertonic saline

Outcome Measures

Primary Outcomes (1)

  • Duration of Mechanical Ventilation

    typically 4 days - 2 weeks

Secondary Outcomes (8)

  • Atelectasis

    during mechanical ventilation (typically 4 days - 2 weeks)

  • Wheezing

    during mechanical ventilation (typically 4 days - 2 weeks)

  • ICU Length of Stay

    during hospitalization (typically 4 days - 2 weeks)

  • Hospital Length of Stay

    during hospitalization (typically 4 days - 2 weeks)

  • Change in Serum Sodium From Baseline

    during hospitalization (typically 4 days - 2 weeks)

  • +3 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days

Drug: Placebo (0.9% saline)

Hypertonic Saline

EXPERIMENTAL

Hypertonic saline (3%), 3mL every 6hrs for up to 7 days

Drug: Hypertonic saline (3%)

Interventions

Hypertonic saline (3%)DRUG

3mL of HTS given via nebulizer every 6hrs

Also known as: 3% saline
Hypertonic Saline
Placebo (0.9% saline)DRUG

3mL of normal saline given via nebulizer every 6hrs

Also known as: normal saline
Placebo

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • invasive mechanical ventilation of \< 12 hrs duration prior to enrollment
  • expected duration of mechanical ventilation of \> 48hrs from enrollment
  • age \< 18yo

You may not qualify if:

  • cystic fibrosis
  • status asthmaticus
  • pulmonary hemorrhage/contusion
  • home O2 use
  • home non-invasive positive pressure (CPAP/BiPAP) ventilation use
  • pre-existing tracheostomy
  • prescription of mucolytic medication by primary clinical team
  • allergy to inhaled saline/hypertonic saline or albuterol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center)

Cleveland, Ohio, 44106, United States

Location

Related Publications (9)

  • Payen V, Jouvet P, Lacroix J, Ducruet T, Gauvin F. Risk factors associated with increased length of mechanical ventilation in children. Pediatr Crit Care Med. 2012 Mar;13(2):152-7. doi: 10.1097/PCC.0b013e3182257a24.

    PMID: 21760567BACKGROUND

  • Riethmueller J, Borth-Bruhns T, Kumpf M, Vonthein R, Wiskirchen J, Stern M, Hofbeck M, Baden W. Recombinant human deoxyribonuclease shortens ventilation time in young, mechanically ventilated children. Pediatr Pulmonol. 2006 Jan;41(1):61-6. doi: 10.1002/ppul.20298.

    PMID: 16265663BACKGROUND

  • Dilmen U, Karagol BS, Oguz SS. Nebulized hypertonic saline and recombinant human DNase in the treatment of pulmonary atelectasis in newborns. Pediatr Int. 2011 Jun;53(3):328-31. doi: 10.1111/j.1442-200X.2010.03245.x.

    PMID: 20831650BACKGROUND

  • Prodhan P, Greenberg B, Bhutta AT, Hyde C, Vankatesan A, Imamura M, Jaquiss RD, Dyamenahalli U. Recombinant human deoxyribonuclease improves atelectasis in mechanically ventilated children with cardiac disease. Congenit Heart Dis. 2009 May-Jun;4(3):166-73. doi: 10.1111/j.1747-0803.2009.00289.x.

    PMID: 19489944BACKGROUND

  • Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006458. doi: 10.1002/14651858.CD006458.pub2.

    PMID: 18843717BACKGROUND

  • Rosenfeld M, Ratjen F, Brumback L, Daniel S, Rowbotham R, McNamara S, Johnson R, Kronmal R, Davis SD; ISIS Study Group. Inhaled hypertonic saline in infants and children younger than 6 years with cystic fibrosis: the ISIS randomized controlled trial. JAMA. 2012 Jun 6;307(21):2269-77. doi: 10.1001/jama.2012.5214.

    PMID: 22610452BACKGROUND

  • Elkins MR, Robinson M, Rose BR, Harbour C, Moriarty CP, Marks GB, Belousova EG, Xuan W, Bye PT; National Hypertonic Saline in Cystic Fibrosis (NHSCF) Study Group. A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. N Engl J Med. 2006 Jan 19;354(3):229-40. doi: 10.1056/NEJMoa043900.

    PMID: 16421364BACKGROUND

  • Altunhan H, Annagur A, Pekcan S, Ors R, Koc H. Comparing the efficacy of nebulizer recombinant human DNase and hypertonic saline as monotherapy and combined treatment in the treatment of persistent atelectasis in mechanically ventilated newborns. Pediatr Int. 2012 Feb;54(1):131-6. doi: 10.1111/j.1442-200X.2011.03519.x.

    PMID: 22114907BACKGROUND

  • Youness HA, Mathews K, Elya MK, Kinasewitz GT, Keddissi JI. Dornase alpha compared to hypertonic saline for lung atelectasis in critically ill patients. J Aerosol Med Pulm Drug Deliv. 2012 Dec;25(6):342-8. doi: 10.1089/jamp.2011.0954. Epub 2012 Mar 13.

    PMID: 22413805BACKGROUND

MeSH Terms

Conditions

Respiratory InsufficiencyPulmonary Atelectasis

Interventions

Saline Solution, HypertonicSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesLung Diseases

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic Solutions

Limitations and Caveats

As shown above, baseline lung function (as measured by PEEP) was worse in the treatment (HTS) group.

Results Point of Contact

Title
Steven Shein, MD
Organization
Rainbow Babies and Children's Hospital
drstevenshein@gmail.com
216-844-3310

Study Officials

  • Steven L Shein, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 19, 2013

Study Start

October 1, 2013

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

June 28, 2016

Results First Posted

June 28, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)