AnesthesiaPhase 3NCT03054922
Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables
A Phase 3 study testing Normal Saline, Lactated Ringer and Normosol-R Inj in people with Anesthesia, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
During major surgical procedures, intravascular volume is maintained with the administration of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three of these fluids are in common clinical use for this purpose. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Normal Saline, Lactated Ringer and Normosol-R Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2017to 30 Sep 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Major surgical procedure requiring arterial access
Who cannot join
- Comorbid disease process that contraindicates the use of any 1 of the 3 crystalloid solutions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
During major surgical procedures, intravascular volume is maintained with the administration of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three of these fluids are in common clinical use for this purpose. As large volumes of NS may result in a dilutional acidosis and an increasing base deficit, it may cloud clinical decision making when resuscitative efforts are guided by acid-base status on routine arterial blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids for intraoperative resuscitation.
- Conditions
- Anesthesia
- Being tested
- Normal Saline, Lactated Ringer, Normosol-R Inj
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
Also called 0.9% NaCl
IV infusion of 0.9% NaCl throughout surgery.
Lactated RingerDrug
IV infusion of lactated ringer throughout surgery.
Normosol-R InjDrug
IV infusion of Normosol throughout surgery.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Active comparator | 0.9% Sodium Chloride Receives: Drug: Normal Saline |
| Lactated Ringers | Active comparator | Each 100 mL of Lactated Ringer's Injection USP contains:
Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs Receives: Drug: Lactated Ringer |
| Normosol-R | Active comparator | Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg. Receives: Drug: Normosol-R Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Base Deficit
Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis
Measured: During surgery (typically 4-6 hrs in length)
Secondary outcomes (4)
Change in Sodium
Change in sodium electrolyte from 1st to 2nd blood gas
Measured: During surgery (typically 4-6 hrs in length)
Change in Potassium
Change in potassium electrolyte from 1st to 2nd blood gas
Measured: During surgery (typically 4-6 hrs in length)
Change in Ionized Calcium
Change in calcium electrolyte from 1st to 2nd blood gas
Measured: During surgery (typically 4-6 hrs in length)
Change in pH
Change in pH from 1st to 2nd blood gas
Measured: During surgery (typically 4-6 hrs in length)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start23 Feb 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David P. Martin, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054922
- Sponsor's protocol ID
- IRB16-01093
- Status last verified
- Mar 2020
- First submitted
- 13 Feb 2017
- Last updated
- 25 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables
- ClinicalTrials.gov ID
- NCT03054922
- Acronym / sponsor ID
- IRB16-01093
- Conditions
- Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Posted 25 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During major surgical procedures, intravascular volume is maintained with the administration of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three of these fluids are in common clinical use for this purpose. As large volumes of NS may result in a dilutional acidosis and an increasing base deficit, it may cloud clinical decision making when resuscitative efforts are guided by acid-base status on routine arterial blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids for intraoperative resuscitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Active comparator | Drug: Normal Saline0.9% Sodium Chloride |
| Lactated Ringers | Active comparator | Drug: Lactated RingerEach 100 mL of Lactated Ringer's Injection USP contains: Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs |
| Normosol-R | Active comparator | Drug: Normosol-R InjEach 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Major surgical procedure requiring arterial access
Key exclusion criteria (1 listed)
- Comorbid disease process that contraindicates the use of any 1 of the 3 crystalloid solutions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal SalineAlso: 0.9% NaClIV infusion of 0.9% NaCl throughout surgery. | Drug | Normal Saline |
| Lactated RingerIV infusion of lactated ringer throughout surgery. | Drug | Lactated Ringers |
| Normosol-R InjIV infusion of Normosol throughout surgery. | Drug | Normosol-R |
Primary outcome
Change in Base Deficit
Time frame: During surgery (typically 4-6 hrs in length)
Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis
4 secondary outcomes
Change in Sodium
Time frame: During surgery (typically 4-6 hrs in length)
Change in Potassium
Time frame: During surgery (typically 4-6 hrs in length)
Change in Ionized Calcium
Time frame: During surgery (typically 4-6 hrs in length)
Change in pH
Time frame: During surgery (typically 4-6 hrs in length)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Normal Saline, Lactated Ringer and Normosol-R Inj in people with Anesthesia, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Base Deficit (time frame: During surgery (typically 4-6 hrs in length)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.