NCT01458873

Brief Summary

Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2. The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 1, 2011

Status Verified

October 1, 2011

Enrollment Period

1.2 years

First QC Date

October 9, 2011

Last Update Submit

October 30, 2011

Conditions

InfiltrationExtravasation

Keywords

infiltrationextravasation

Outcome Measures

Primary Outcomes (1)

  • transient increase in end tidal carbon dioxide

    Once sodium bicarbonate is injected the measured end-tidal carbon dioxide will transiently increase by at least 10% of baseline

    4-12 seconds

Secondary Outcomes (5)

  • Change in venous blood pH

    10-20 minutes

  • Subjective adverse symptoms associated with injection of sodium bicarbonate

    1 minute

  • change in venous blood sodium

    10- 20 minutes

  • change in venous blood bicarbonate level

    10-20 minutes

  • change in venous blood potasium level

    10-20 minutes

Study Arms (3)

sodium bicarbonate 4.2%

EXPERIMENTAL

sodium bicarbonate 4.2% 50 m"l

Drug: sodium bicarbonate 4.2%

sodium bicarbonate 2.1%

EXPERIMENTAL

sodium bicarbonate 2.1% 1 50 m"l

Drug: diluted sodium bicarbonate 2.1%

normal saline

PLACEBO COMPARATOR

50 m"l normal saline

Drug: normal saline

Interventions

sodium bicarbonate 4.2%DRUG

diluted sodium bicarbonate 50 ml

sodium bicarbonate 4.2%
diluted sodium bicarbonate 2.1%DRUG

50ml

Also known as: sodium bicarbonate 2.1%
sodium bicarbonate 2.1%
normal salineDRUG

50ml

normal saline

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I,II
  • no cardiovascular or respiratory disease

You may not qualify if:

  • ASA \> II
  • Cardiovascular disease
  • Respiratory disease
  • renal failure
  • metabolic alkalosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

Related Publications (2)

  • Keidan I, Ben-Menachem E, Barzilai A, Nur I, Berkenstadt H. Intravenous sodium bicarbonate verifies intravenous position of catheters in ventilated patients. Anesth Analg. 2011 Aug;113(2):279-81. doi: 10.1213/ANE.0b013e3182222ed0. Epub 2011 Jun 3.

    PMID: 21642603BACKGROUND

  • Keidan I, Sidi A, Ben-Menachem E, Derazne E, Berkenstadt H. A simple diagnostic test to confirm correct intravascular placement of peripheral catheters in order to avoid extravasation. J Clin Anesth. 2015 Nov;27(7):585-8. doi: 10.1016/j.jclinane.2015.07.004. Epub 2015 Aug 15.

    PMID: 26286133DERIVED

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

ILAN KEIDAN, MD

CONTACT

972-3-5302754ilan.keidan@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Pediatric Anesthesia, Sheba Medical center

Study Record Dates

First Submitted

October 9, 2011

First Posted

October 25, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 1, 2011

Record last verified: 2011-10

Locations

IL(1)