Dehydration in ChildrenEarly Phase 1BRiSKNCT05285371
Boluses of Ringer's in Surgical Kids (BRiSK Study)
A Early Phase 1 study testing Urinalysis (UA), Complete Metabolic Panel (CMP) and Glucose Stick Test (d-Stick) in people with Dehydration in Children and Fluid Therapy, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Traditional protocols for intravenous fluid administration in children who have undergone a major abdominal or thoracic operation are based on a landmark paper published in 1957 by Holliday and Segar. Read more about this study
- Who is it for?
- Ages 1 year to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration in Children, Fluid Therapy
- What is being tested?
- Urinalysis (UA), Complete Metabolic Panel (CMP) and Glucose Stick Test (d-Stick)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2022to 1 Aug 2024
- Phase
- Early Phase 1
- 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 year to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Males or females age 12 months to 21 years.
- Weight >= 8 kg.
- Patients with an uncomplicated abdominal or thoracic surgical procedure in which the expected postoperative length of stay is anticipated to be at least 2-5 days.
- Patients admitted to a regular bed following surgery.
- Patients who will be inpatient for approximately 4-8 days postoperatively.
- Parental/guardian permission (informed consent).
Who cannot join
- Patients with a history of diabetes, seizures, hyperglycemia, and hypoglycemia.
- Patients prescribed insulin.
- Patients receiving parenteral nutrition.
- Patients with excessive GI losses (small bowel obstruction, severe diarrhea, large-volume ascites or drainage).
- Complicated surgery that requires an ICU or ICU transfer immediately after surgery.
- Patients with any form of hypersensitivity to the study fluids.
Show all 16Show fewer
- Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease:
- Serum Sodium <130 or >145 mmol/L
- Serum Potassium <3.0 or >5.0 mEq/L
- Serum Chloride <90 or >110 mEq/L
- Serum Creatinine ≥ 1.6 mg/dL
- Serum Glucose <60 or >180 mg/dL
- Alanine Aminotransferase >200 U/L
- Total Bilirubin >12.0 mg/dL
- Pregnant or lactating females.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Intravenous Hydration After Surgery Using Boluses of Balanced Salt Solution
Traditional protocols for intravenous fluid administration in children who have undergone a major abdominal or thoracic operation are based on a landmark paper published in 1957 by Holliday and Segar. The basic tenets include: (1) Continuous intravenous fluid administration; (2) Total fluid volume based on the "4:2:1" rule; (3) Use of hypotonic electrolyte solutions, most commonly 0.45% sodium chloride (NaCl) + 20 milliequivalents per liter (mEq/L) potassium chloride (KCl); and (4) Inclusion of 5% dextrose to increase the osmolarity of the infusate and to help prevent ketosis and acidemia.
Read the detailed description
Recent studies have questioned the validity of each of these tenets. Maintenance rate as defined by Holliday \& Segar is postulated to be in excess of pediatric patients' post-surgical fluid needs. The investigators propose a novel protocol for the administration of IV fluids to children after major abdominal or thoracic surgery that includes: (1) Intermittent boluses; (2) Total volume administered in 24 hours closer to 2/3 of the traditional maintenance fluid requirements; and (3) Use of a balanced salt solution (Lactated Ringer).
- Conditions
- Dehydration in Children, Fluid Therapy
- Being tested
- Urinalysis (UA), Complete Metabolic Panel (CMP), Glucose Stick Test (d-Stick), Medical Chart Review
- Keywords
- Hydration, Fluids, Lactated Ringer's, Hyponatremia, Dehydration, Post Operative, Pediatrics, Children, Intravenous Fluid Therapy
- Medical subject headings
- Hyponatremia, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinalysis (UA)Diagnostic test
Urinalysis will be performed twice daily starting on Postoperative Day 0.
Complete Metabolic Panel (CMP)Diagnostic test
A CMP will be performed on Postoperative Day 2 and Postoperative Day 4.
Glucose Stick Test (d-Stick)Diagnostic test
A d-Stick will be performed twice daily except on Postoperative Day 2 and Postoperative Day 4 as the CMP includes serum glucose levels.
Medical Chart ReviewOther
A medical chart review will be performed for all subjects enrolled.
| Study group | Role | What they receive |
|---|---|---|
| CONT Group | Placebo comparator | CONT group will receive standard traditional intravenous fluid of D50.45% NaCl + 20 mEq/L KCl at 2/3 maintenance rate. Receives: Diagnostic Test: Urinalysis (UA); Diagnostic Test: Complete Metabolic Panel (CMP); Diagnostic Test: Glucose Stick Test (d-Stick); Other: Medical Chart Review |
| BOL Group | Experimental | BOL group will receive intravenous boluses of Lactated Ringer's three times daily at 2/3 maintenance rate. Receives: Diagnostic Test: Urinalysis (UA); Diagnostic Test: Complete Metabolic Panel (CMP); Diagnostic Test: Glucose Stick Test (d-Stick); Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid Adherence to Study Protocol
Feasibility will be determined if 85% of enrolled study participants receive at least 75% of the expected study fluid in accordance to study protocol.
Measured: 4 Days
Feasibility of Measuring and Collecting Urine Output
Feasibility will be determined if at least 90% of enrolled study participants have accurate urine collection and urine measurements during the study treatment phase.
Measured: 4 Days
Secondary outcomes (2)
Feasibility of Study Laboratory Tests - CMP, d-Stick, Urinalysis
Feasibility will be determined if at least 70% of enrolled study participants have at least 75% of study laboratory tests collected and recorded during the study treatment phase.
Measured: 4 Days
Feasibility of Randomization
Feasibility will be determined if at least 85% of eligible study participants are subsequently enrolled, consented, and randomized during their pre-operative phase of care.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start22 Feb 2022
- Primary completion19 Apr 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Dehydration in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be randomized into one of two groups - Continuous (CONT) or Bolus (BOL). CONT group will receive traditional continuous D50.45% NaCl + 20 mEq/L KCl solution at 2/3 maintenance rate. BOL group will receive intravenous boluses of Lactated Ringer\'s at 2/3-maintenance rate.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Mattei, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285371
- Sponsor's protocol ID
- 21-019180
- Acronym
- BRiSK
- Status last verified
- Sep 2024
- First submitted
- 9 Mar 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
McNab S. Intravenous maintenance fluid therapy in children. J Paediatr Child Health. 2016 Feb;52(2):137-40. doi: 10.1111/jpc.13076.
PubMed 27062616Rooholamini SN, Clifton H, Haaland W, McGrath C, Vora SB, Crowell CS, Romero H, Foti J. Outcomes of a Clinical Pathway to Standardize Use of Maintenance Intravenous Fluids. Hosp Pediatr. 2017 Dec;7(12):703-709. doi: 10.1542/hpeds.2017-0099.
PubMed 29162640Neville KA, Sandeman DJ, Rubinstein A, Henry GM, McGlynn M, Walker JL. Prevention of hyponatremia during maintenance intravenous fluid administration: a prospective randomized study of fluid type versus fluid rate. J Pediatr. 2010 Feb;156(2):313-9.e1-2. doi: 10.1016/j.jpeds.2009.07.059. Epub 2009 Oct 9.
PubMed 19818450Bagri NK, Saurabh VK, Basu S, Kumar A. Isotonic versus Hypotonic Intravenous Maintenance Fluids in Children: A Randomized Controlled Trial. Indian J Pediatr. 2019 Nov;86(11):1011-1016. doi: 10.1007/s12098-019-03011-5. Epub 2019 Jul 6.
PubMed 31280410Morgan JA. Question 2: Should 0.9% saline be used for maintenance fluids in hospitalised children? Arch Dis Child. 2015 Jul;100(7):715-7. doi: 10.1136/archdischild-2015-308821. Epub 2015 May 20. No abstract available.
PubMed 25994003Moritz ML. Syndrome of Inappropriate Antidiuresis. Pediatr Clin North Am. 2019 Feb;66(1):209-226. doi: 10.1016/j.pcl.2018.09.005.
PubMed 30454744Feld LG, Neuspiel DR, Foster BA, Leu MG, Garber MD, Austin K, Basu RK, Conway EE Jr, Fehr JJ, Hawkins C, Kaplan RL, Rowe EV, Waseem M, Moritz ML; SUBCOMMITTEE ON FLUID AND ELECTROLYTE THERAPY. Clinical Practice Guideline: Maintenance Intravenous Fluids in Children. Pediatrics. 2018 Dec;142(6):e20183083. doi: 10.1542/peds.2018-3083.
PubMed 30478247Friedman JN, Beck CE, DeGroot J, Geary DF, Sklansky DJ, Freedman SB. Comparison of isotonic and hypotonic intravenous maintenance fluids: a randomized clinical trial. JAMA Pediatr. 2015 May;169(5):445-51. doi: 10.1001/jamapediatrics.2014.3809.
PubMed 25751673Moritz ML, Ayus JC. Hospital-acquired hyponatremia--why are hypotonic parenteral fluids still being used? Nat Clin Pract Nephrol. 2007 Jul;3(7):374-82. doi: 10.1038/ncpneph0526.
PubMed 17592470Oh GJ, Sutherland SM. Perioperative fluid management and postoperative hyponatremia in children. Pediatr Nephrol. 2016 Jan;31(1):53-60. doi: 10.1007/s00467-015-3081-y. Epub 2015 Mar 18.
PubMed 25784018Abdessalam S. Hypotonic versus isotonic maintenance fluid administration in the pediatric surgical patient. Semin Pediatr Surg. 2019 Feb;28(1):43-46. doi: 10.1053/j.sempedsurg.2019.01.007. Epub 2019 Jan 23.
PubMed 30824133McNab S, Ware RS, Neville KA, Choong K, Coulthard MG, Duke T, Davidson A, Dorofaeff T. Isotonic versus hypotonic solutions for maintenance intravenous fluid administration in children. Cochrane Database Syst Rev. 2014 Dec 18;2014(12):CD009457. doi: 10.1002/14651858.CD009457.pub2.
PubMed 25519949Easley D, Tillman E. Hospital-acquired hyponatremia in pediatric patients: a review of the literature. J Pediatr Pharmacol Ther. 2013 Apr;18(2):105-11. doi: 10.5863/1551-6776-18.2.105.
PubMed 23798904Moritz ML, Ayus JC. Prevention of hospital-acquired hyponatremia: a case for using isotonic saline. Pediatrics. 2003 Feb;111(2):227-30. doi: 10.1542/peds.111.2.227.
PubMed 12563043Malbrain MLNG, Langer T, Annane D, Gattinoni L, Elbers P, Hahn RG, De Laet I, Minini A, Wong A, Ince C, Muckart D, Mythen M, Caironi P, Van Regenmortel N. Intravenous fluid therapy in the perioperative and critical care setting: Executive summary of the International Fluid Academy (IFA). Ann Intensive Care. 2020 May 24;10(1):64. doi: 10.1186/s13613-020-00679-3.
PubMed 32449147
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Hydration After Surgery Using Boluses of Balanced Salt Solution
- ClinicalTrials.gov ID
- NCT05285371
- Acronym / sponsor ID
- BRiSK / 21-019180
- Conditions
- Dehydration in Children, Fluid Therapy
- Keywords
- Hydration, Fluids, Lactated Ringer's, Hyponatremia, Dehydration, Post Operative, Pediatrics, Children
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 17 Mar 2022 (actual)
- 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.
Traditional protocols for intravenous fluid administration in children who have undergone a major abdominal or thoracic operation are based on a landmark paper published in 1957 by Holliday and Segar. The basic tenets include: (1) Continuous intravenous fluid administration; (2) Total fluid volume based on the "4:2:1" rule; (3) Use of hypotonic electrolyte solutions, most commonly 0.45% sodium chloride (NaCl) + 20 milliequivalents per liter (mEq/L) potassium chloride (KCl); and (4) Inclusion of 5% dextrose to increase the osmolarity of the infusate and to help prevent ketosis and acidemia.
Detailed description
Recent studies have questioned the validity of each of these tenets. Maintenance rate as defined by Holliday \& Segar is postulated to be in excess of pediatric patients' post-surgical fluid needs. The investigators propose a novel protocol for the administration of IV fluids to children after major abdominal or thoracic surgery that includes: (1) Intermittent boluses; (2) Total volume administered in 24 hours closer to 2/3 of the traditional maintenance fluid requirements; and (3) Use of a balanced salt solution (Lactated Ringer).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study participants will be randomized into one of two groups - Continuous (CONT) or Bolus (BOL). CONT group will receive traditional continuous D50.45% NaCl + 20 mEq/L KCl solution at 2/3 maintenance rate. BOL group will receive intravenous boluses of Lactated Ringer\'s at 2/3-maintenance rate.
| Arm | Type | Receives |
|---|---|---|
| CONT Group | Placebo comparator | Diagnostic Test: Urinalysis (UA), Diagnostic Test: Complete Metabolic Panel (CMP), Diagnostic Test: Glucose Stick Test (d-Stick), Other: Medical Chart ReviewCONT group will receive standard traditional intravenous fluid of D50.45% NaCl + 20 mEq/L KCl at 2/3 maintenance rate. |
| BOL Group | Experimental | Diagnostic Test: Urinalysis (UA), Diagnostic Test: Complete Metabolic Panel (CMP), Diagnostic Test: Glucose Stick Test (d-Stick), Other: Medical Chart ReviewBOL group will receive intravenous boluses of Lactated Ringer's three times daily at 2/3 maintenance rate. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Males or females age 12 months to 21 years.
- Weight >= 8 kg.
- Patients with an uncomplicated abdominal or thoracic surgical procedure in which the expected postoperative length of stay is anticipated to be at least 2-5 days.
- Patients admitted to a regular bed following surgery.
- Patients who will be inpatient for approximately 4-8 days postoperatively.
Key exclusion criteria (16 listed)
- Patients with a history of diabetes, seizures, hyperglycemia, and hypoglycemia.
- Patients prescribed insulin.
- Patients receiving parenteral nutrition.
- Patients with excessive GI losses (small bowel obstruction, severe diarrhea, large-volume ascites or drainage).
- Complicated surgery that requires an ICU or ICU transfer immediately after surgery.
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 |
|---|---|---|
| Urinalysis (UA)Urinalysis will be performed twice daily starting on Postoperative Day 0. | Diagnostic test | BOL Group, CONT Group |
| Complete Metabolic Panel (CMP)A CMP will be performed on Postoperative Day 2 and Postoperative Day 4. | Diagnostic test | BOL Group, CONT Group |
| Glucose Stick Test (d-Stick)A d-Stick will be performed twice daily except on Postoperative Day 2 and Postoperative Day 4 as the CMP includes serum glucose levels. | Diagnostic test | BOL Group, CONT Group |
| Medical Chart ReviewA medical chart review will be performed for all subjects enrolled. | Other | BOL Group, CONT Group |
Primary outcome
Fluid Adherence to Study Protocol
Time frame: 4 Days
Feasibility will be determined if 85% of enrolled study participants receive at least 75% of the expected study fluid in accordance to study protocol.
Feasibility of Measuring and Collecting Urine Output
Time frame: 4 Days
Feasibility will be determined if at least 90% of enrolled study participants have accurate urine collection and urine measurements during the study treatment phase.
2 secondary outcomes
Feasibility of Study Laboratory Tests - CMP, d-Stick, Urinalysis
Time frame: 4 Days
Feasibility of Randomization
Time frame: Baseline
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 19 Sep 2024.
- Background: PubMed 27062616McNab S. Intravenous maintenance fluid therapy in children. J Paediatr Child Health. 2016 Feb;52(2):137-40. doi: 10.1111/jpc.13076.
- Background: PubMed 29162640Rooholamini SN, Clifton H, Haaland W, McGrath C, Vora SB, Crowell CS, Romero H, Foti J. Outcomes of a Clinical Pathway to Standardize Use of Maintenance Intravenous Fluids. Hosp Pediatr. 2017 Dec;7(12):703-709. doi: 10.1542/hpeds.2017-0099.
- Background: PubMed 19818450Neville KA, Sandeman DJ, Rubinstein A, Henry GM, McGlynn M, Walker JL. Prevention of hyponatremia during maintenance intravenous fluid administration: a prospective randomized study of fluid type versus fluid rate. J Pediatr. 2010 Feb;156(2):313-9.e1-2. doi: 10.1016/j.jpeds.2009.07.059. Epub 2009 Oct 9.
- Background: PubMed 31280410Bagri NK, Saurabh VK, Basu S, Kumar A. Isotonic versus Hypotonic Intravenous Maintenance Fluids in Children: A Randomized Controlled Trial. Indian J Pediatr. 2019 Nov;86(11):1011-1016. doi: 10.1007/s12098-019-03011-5. Epub 2019 Jul 6.
- Background: PubMed 25994003Morgan JA. Question 2: Should 0.9% saline be used for maintenance fluids in hospitalised children? Arch Dis Child. 2015 Jul;100(7):715-7. doi: 10.1136/archdischild-2015-308821. Epub 2015 May 20. No abstract available.
- Background: PubMed 30454744Moritz ML. Syndrome of Inappropriate Antidiuresis. Pediatr Clin North Am. 2019 Feb;66(1):209-226. doi: 10.1016/j.pcl.2018.09.005.
- Background: PubMed 30478247Feld LG, Neuspiel DR, Foster BA, Leu MG, Garber MD, Austin K, Basu RK, Conway EE Jr, Fehr JJ, Hawkins C, Kaplan RL, Rowe EV, Waseem M, Moritz ML; SUBCOMMITTEE ON FLUID AND ELECTROLYTE THERAPY. Clinical Practice Guideline: Maintenance Intravenous Fluids in Children. Pediatrics. 2018 Dec;142(6):e20183083. doi: 10.1542/peds.2018-3083.
- Background: PubMed 25751673Friedman JN, Beck CE, DeGroot J, Geary DF, Sklansky DJ, Freedman SB. Comparison of isotonic and hypotonic intravenous maintenance fluids: a randomized clinical trial. JAMA Pediatr. 2015 May;169(5):445-51. doi: 10.1001/jamapediatrics.2014.3809.
- Background: PubMed 17592470Moritz ML, Ayus JC. Hospital-acquired hyponatremia--why are hypotonic parenteral fluids still being used? Nat Clin Pract Nephrol. 2007 Jul;3(7):374-82. doi: 10.1038/ncpneph0526.
- Background: PubMed 25784018Oh GJ, Sutherland SM. Perioperative fluid management and postoperative hyponatremia in children. Pediatr Nephrol. 2016 Jan;31(1):53-60. doi: 10.1007/s00467-015-3081-y. Epub 2015 Mar 18.
- Background: PubMed 30824133Abdessalam S. Hypotonic versus isotonic maintenance fluid administration in the pediatric surgical patient. Semin Pediatr Surg. 2019 Feb;28(1):43-46. doi: 10.1053/j.sempedsurg.2019.01.007. Epub 2019 Jan 23.
- Background: PubMed 25519949McNab S, Ware RS, Neville KA, Choong K, Coulthard MG, Duke T, Davidson A, Dorofaeff T. Isotonic versus hypotonic solutions for maintenance intravenous fluid administration in children. Cochrane Database Syst Rev. 2014 Dec 18;2014(12):CD009457. doi: 10.1002/14651858.CD009457.pub2.
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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.
Peter Mattei, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Urinalysis (UA), Complete Metabolic Panel (CMP) and Glucose Stick Test (d-Stick) in people with Dehydration in Children and Fluid Therapy, run by Children's Hospital of Philadelphia 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 6 inclusion and 16 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 19 Sep 2024. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Fluid Adherence to Study Protocol (time frame: 4 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05285371, which also lists 20 linked publications.
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 19 Sep 2024.