Shock, SepticPhase 3NCT02336620
Balanced Salt Solution VS. Normal Saline Solution in Septic Shock
A Phase 3 study testing Ringer acetate and Normal saline in people with Shock, Septic and Sepsis, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
The Purpose of this study is to determine the impact of balanced salt solution versus chloride rich solution on clinical outcomes in paediatric severe sepsis or septic shock Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Shock, Septic, Sepsis
- What is being tested?
- Ringer acetate and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2014to 30 Jan 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children younger than 18 year old who has severe sepsis or septic shock
- inform consent
Who cannot join
- children who had shock from other aetiologies
- end stage disease or severe congenital anomaly
- refuse to inform consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balanced Salt Solution Versus Normal Saline Solution During Initial Resuscitation in Severe Sepsis or Septic Shock Children: A Randomized Controlled Trial
The Purpose of this study is to determine the impact of balanced salt solution versus chloride rich solution on clinical outcomes in paediatric severe sepsis or septic shock
Read the detailed description
The surviving sepsis campaign guideline recommended the isotonic crystalloids as the first choice of initial fluid resuscitation. The isotonic crystalloids are including chloride-rich solution (eg.NSS) and balanced salt solution. Retrospective study showed normal saline can induced hyperchloremic metabolic acidosis and acute kidney injury. However, no randomized controlled trial compare efficacy between the balanced salt solution and chloride rich solution.
- Conditions
- Shock, Septic, Sepsis
- Being tested
- Ringer acetate, Normal saline
- Keywords
- Severe sepsis, Balanced Salt Solution, Normal Saline
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer acetateDrug
Ringer acetate 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status
Normal salineDrug
Also called NSS
NSS 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status
| Study group | Role | What they receive |
|---|---|---|
| Ringer Acetate | Experimental | Ringer acetate 10-20 ml/kg IV bolus when patient need fluid bolus Receives: Drug: Ringer acetate |
| Normal saline | Active comparator | NSS 10-20 ml/kg IV bolus when patient need fluid bolus Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hyperchloremic metabolic acidosis
Measured: 48 hour
Secondary outcomes (1)
28 day and 90 day mortality rate
Measured: 28 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startDec 2014
- Primary completion30 Jan 2017
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock, SepticStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Anantasit, Ramathibodi Hospital
- Investigators
- Nattachai Anantasit, M.D., Principal investigator, Ramathibodi Hospital, Bangkok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336620
- Sponsor's protocol ID
- RF_58015
- Status last verified
- Apr 2017
- First submitted
- 8 Jan 2015
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balanced Salt Solution Versus Normal Saline Solution During Initial Resuscitation in Severe Sepsis or Septic Shock Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02336620
- Acronym / sponsor ID
- RF_58015
- Conditions
- Shock, Septic, Sepsis
- Keywords
- Severe sepsis, Balanced Salt Solution, Normal Saline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Purpose of this study is to determine the impact of balanced salt solution versus chloride rich solution on clinical outcomes in paediatric severe sepsis or septic shock
Detailed description
The surviving sepsis campaign guideline recommended the isotonic crystalloids as the first choice of initial fluid resuscitation. The isotonic crystalloids are including chloride-rich solution (eg.NSS) and balanced salt solution. Retrospective study showed normal saline can induced hyperchloremic metabolic acidosis and acute kidney injury. However, no randomized controlled trial compare efficacy between the balanced salt solution and chloride rich solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ringer Acetate | Experimental | Drug: Ringer acetateRinger acetate 10-20 ml/kg IV bolus when patient need fluid bolus |
| Normal saline | Active comparator | Drug: Normal salineNSS 10-20 ml/kg IV bolus when patient need fluid bolus |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children younger than 18 year old who has severe sepsis or septic shock
- inform consent
Key exclusion criteria (3 listed)
- children who had shock from other aetiologies
- end stage disease or severe congenital anomaly
- refuse to inform consent
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 |
|---|---|---|
| Ringer acetateRinger acetate 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status | Drug | Ringer Acetate |
| Normal salineAlso: NSSNSS 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status | Drug | Normal saline |
Primary outcome
incidence of hyperchloremic metabolic acidosis
Time frame: 48 hour
1 secondary outcome
28 day and 90 day mortality rate
Time frame: 28 days and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
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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.
Nattachai Anantasit, M.D. principal investigator
Ramathibodi Hospital, Bangkok
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 Ringer acetate and Normal saline in people with Shock, Septic and Sepsis, run by Ramathibodi Hospital at 1 site in Thailand.
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 2 inclusion and 3 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 26 Apr 2017. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence of hyperchloremic metabolic acidosis (time frame: 48 hour). 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 26 Apr 2017.