HypogammaglobulinemiaNCT02043379
Post-bypass Prophylactic IVIG in Infants and Neonates
A study testing IVIG in people with Hypogammaglobulinemia and Congenital Heart Disease, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study protocol is to determine if administering Intravenous Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes (i.e., infection, fluid overload, and associated morbidities). Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Hypogammaglobulinemia, Congenital Heart Disease
- What is being tested?
- IVIG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jun 2015
- Phase
- Interventional
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants <6 months old
- Successfully weaned off cardiopulmonary bypass after cardiac surgery
Who cannot join
- Requirement of extra corporeal membrane oxygenation in the operating room
- Known immune deficiency
- Current Do Not Resuscitate or limitation of care order
- Current enrollment in another interventional clinical study
- Refusal of parental consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Immunoglobulin for Early Prevention of Cardiopulmonary Bypass Induced Hypogammaglobulinemia in Infants and Neonates
The purpose of this study protocol is to determine if administering Intravenous Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes (i.e., infection, fluid overload, and associated morbidities).
Read the detailed description
The intense post-CPB systemic inflammatory response syndrome (SIRS) is well described in neonates and infants. Increased production and release of pro-inflammatory cytokines, including Tumor Necrosis Factor, Interleukin1-B, and Interleukin-6 may suppress myocardial contractility, induce capillary leak, and activate complement and the clotting cascade - together leading to potential organ injury and death. SIRS is also frequently accompanied by impairment of the humoral immune response. One potential reason for this acquired immunodeficiency after cardiac surgery is the removal of immunoglobulins (Ig)s from the vascular space into other compartments where they are either sequestered or lost from the body altogether. We recently demonstrated that such Ig depletion from the intravascular compartment occurs in neonates following cardiac surgery. In a retrospective study of 53 children <3 months of age, we showed that plasma Immunoglobulin G (IgG) concentration drops precipitously after cardiac surgery and does not return to preoperative levels by 7 days; 51% of patients had hypogammaglobulinemia.
An important question is whether post-CPB low IgG has clinical consequence. IgG plays an essential role in the humoral immune system, activating complement and inducing the phagocytic system to neutralize pathogens. IgG deficiency is a known risk factor for infections in other pediatric populations. We were the first to demonstrate that post-CPB hypogammaglobulinemia is associated with worse clinical outcomes, including increased secondary infections (37% vs.12% in those without low IgG, p<0.05). These novel findings are paramount in that they identify a potential modifiable risk factor to improve outcomes after pediatric cardiac surgery with CPB. Additionally, low IgG is accompanied by fluid overload and prolonged mechanical ventilation. Igs constitute an important component of plasma oncotic pressure, so hypogammaglobulinemia may exacerbate anasarca, prolonging postoperative convalescence and increasing the morbidities associated with increased ICU length of stay.9
Igs have an increasingly recognized role in modulating the innate immune response. Present use of IVIG exceeds mere antibody replacement and extends to the treatment of autoimmune and inflammatory conditions. In fact, more than 75% of IVIG use in the U.S. today is for the treatment of inflammatory conditions, where proposed mechanisms include reduction of pro-inflammatory cytokine and adhesion molecule expression, superantigen neutralization, restoration of glucocorticoid responsiveness, and blockade of complement fragment deposition. It is plausible that IVIG could benefit neonates after cardiac surgery not only via restoration of humoral opsonization capacity, but also as a modulator of innate immunity and SIRS. According to this model, tissue injury, CPB, and shock trigger SIRS, leading to hypogammaglobulinemia and resultant increased susceptibility to inflammatory dysregulation which might be ameliorated via administration of IVIG.
In an adult study, IVIG failed to benefit postoperative cardiac patients with severe SIRS. However, the dose of IVIG given was relatively small compared with that typically given for autoimmune and inflammatory conditions. Neonates and infants may be more susceptible to the harmful effects of acquired hypogammaglobulinemia than adults as they may be unable to generate adequate quantities of antibodies in response to pathogens, relying mainly on maternal Igs until around the 4th to 6th month of life. In addition, they display an exaggerated inflammatory response to CPB as compared with older children and adults, so they might stand to benefit more from IVIG as an immunomodulator.
Because of the increased vulnerability to acquired infection and other morbidities in the setting of hypogammaglobulinemia as result of enhanced SIRS and immune dysfunction, it is feasible that normalization of IgG concentration in the neonatal and infant population may improve clinical outcomes via restoration of the humoral immune system, modulation of the innate immune system, and restoration of intravascular oncotic pressure. The appropriate IgG level threshold for treatment and optimal plasma IgG level to target after administration of IVIG are presently unknown.
- Conditions
- Hypogammaglobulinemia, Congenital Heart Disease
- Being tested
- IVIG, Placebo
- Keywords
- congenital heart disease, Cardiopulmonary Bypass, Hypogammaglobulinemia
- Medical subject headings
- Agammaglobulinemia, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIGDrug
Also called Gamunex
Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
PlaceboOther
Also called Normal Saline
If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
| Study group | Role | What they receive |
|---|---|---|
| IVIG | Experimental | Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose and will be administered per hospital standards for IVIG administration. Receives: Drug: IVIG |
| Normal Saline | Placebo comparator | Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. This infusion will be administered as if the subject is receiving IVIG according to hospital policy. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Infections
The primary endpoint of this study is incidence of post-operative infections through hospital discharge
Measured: until Hospital Discharge, an average of 30 days
Post-operative Infection
Any positive culture or treatment for culture negative sepsis within 1 week of surgery
Measured: within 1 week of surgery
Blood Stream Infection
Any positive blood culture during the post-operative period until hospital discharge
Measured: until Hospital Discharge, an average of 30 days
Blood Stream Infection Within 1 Week of Surgery
Measured: 7 days
Secondary outcomes (22)
Post-operative Plasma Albumin
Plasma albumin will be assessed at 24 and 48 hours.
Measured: up to 48 hours post CPB
Fluid Overload Variables
The following fluid overload variables will be assessed in milliliters per kilogram at 0-24 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload. The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.
Measured: 0-24 hours post-CPB
Post-operative Inotrope Score
The average admit, 12 hour, 24 hour, and 48 hour post-operative inotrope score will be calculated excluding Milrinone. To calculate the inotrope score the following formula was used: (Epinephrine/Norepinephrine dose in mcg/kg/min x 100) + (Dopamine dose in mcg/kg/min x 1) + (Phenylephrine dose in mcg/kg/min x 10) + (Vasopressin dose unit/kg/hr x 60/10000). The higher the inotrope score the more cardiac support the subject requires. There is not a "normal" scale or range used for this calculation.
Measured: first 48 hours post-CPB
Respiratory Variables
Alive, ventilator free days will be recorded at hospital discharge.
Measured: until Hospital Discharge, an average of 30 days
Hospital Discharge
From admit post-operative to the Pediatric cardiac intensive care unit until discharge from the hospital in days.
Measured: Approximately 1 month
Plasma Immunoglobulins
Plasma Immunoglobulin levels will be checked pre-operatively, 12 hours post-op and 5 days post-op
Measured: 5 days post-op
Interferon-gamma Plasma Cytokine Levels
Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
Measured: Pre-operative to 48 hours post-operative
Immunoglobulin Concentration in Chest Tube Drainage
Immunoglobulin concentration will be measured from chest tube every 4 hours for first 12 hours post-operative and then 24 hours post-operative.
Measured: 24 hours post-op
Mortality
Incidence of mortality from admit to Pediatric cardiac intensive care unit post-operatively until hospital discharge .
Measured: Approximately 1 month
Intensive Care Unit Length of Stay
The length of stay in the pediatric cardiac intensive care unit from admit post-operative until either discharge home, discharge to another unit/hospital/care facility, or death. This value is calculated in hours. Admit post-operative is recorded as hour 0.
Measured: 1 month
Fluid Overload Variables
The following fluid overload variables will be assessed at 0-24 hours, 25-48 hours, and 0-48 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload.The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.
Measured: 0-48 hours post-CPB
Respiratory Variables
Time until first extubation in hours
Measured: until extubation, an average of 2 days
Respiratory Variables
Total time duration of post-operative length of mechanical ventilation until hospital discharge
Measured: until extubation, an average of 2 days
Interleukin-10 Plasma Cytokine Levels
Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
Measured: pre-operative through 48 hours post-operative
Interleukin-12p70 Plasma Cytokine Levels
Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
Measured: pre-operative through 48 hours post-operative
Interleukin-1b Plasma Cytokine Levels
Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
Measured: pre-operative through 48 hours post-operative
Interleukin-6 Plasma Cytokine Levels
Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
Measured: pre-operative through 48 hours post-operative
Interleukin-8 Plasma Cytokine Levels
Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
Measured: pre-operative through 48 hours post-operative
Tumor Necrosis Factor Plasma Cytokine Levels
Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
Measured: pre-operative through 48 hours post-operative
Immunoglobulin Concentration in Peritoneal Dialysis Drainage
Immunoglobulin concentration will be measured from chest tube and peritoneal drain every 4 hours for first 12 hours post-operative and 24 hours post-operative.
Measured: 24 hours post-op
Serum Creatinine
Pre-operative and 48 hour post-operative maximum creatinine recorded.
Measured: 48 hours
Lactic Acid
Measured: pre-operative through 24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015
- Study completionJun 2015
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 HypogammaglobulinemiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Responsible party
- Principal investigator, Jeffrey Alten, MD, University of Alabama at Birmingham
- Investigators
- Jeffrey Alten, MD, Principal investigator, University of Alabama at Birmingham Pediatric Cardiac Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043379
- Sponsor's protocol ID
- F13114002
- Other IDs
- F13114002
- Status last verified
- Mar 2017
- First submitted
- 14 Jan 2014
- Last updated
- 13 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: IPD will not be shared with other individuals
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Immunoglobulin for Early Prevention of Cardiopulmonary Bypass Induced Hypogammaglobulinemia in Infants and Neonates
- ClinicalTrials.gov ID
- NCT02043379
- Acronym / sponsor ID
- F13114002
- Conditions
- Hypogammaglobulinemia, Congenital Heart Disease
- Keywords
- congenital heart disease, Cardiopulmonary Bypass, Hypogammaglobulinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Study start
- May 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Posted 13 Apr 2017
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 protocol is to determine if administering Intravenous Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes (i.e., infection, fluid overload, and associated morbidities).
Detailed description
The intense post-CPB systemic inflammatory response syndrome (SIRS) is well described in neonates and infants. Increased production and release of pro-inflammatory cytokines, including Tumor Necrosis Factor, Interleukin1-B, and Interleukin-6 may suppress myocardial contractility, induce capillary leak, and activate complement and the clotting cascade - together leading to potential organ injury and death. SIRS is also frequently accompanied by impairment of the humoral immune response. One potential reason for this acquired immunodeficiency after cardiac surgery is the removal of immunoglobulins (Ig)s from the vascular space into other compartments where they are either sequestered or lost from the body altogether. We recently demonstrated that such Ig depletion from the intravascular compartment occurs in neonates following cardiac surgery. In a retrospective study of 53 children <3 months of age, we showed that plasma Immunoglobulin G (IgG) concentration drops precipitously after cardiac surgery and does not return to preoperative levels by 7 days; 51% of patients had hypogammaglobulinemia.
An important question is whether post-CPB low IgG has clinical consequence. IgG plays an essential role in the humoral immune system, activating complement and inducing the phagocytic system to neutralize pathogens. IgG deficiency is a known risk factor for infections in other pediatric populations. We were the first to demonstrate that post-CPB hypogammaglobulinemia is associated with worse clinical outcomes, including increased secondary infections (37% vs.12% in those without low IgG, p<0.05). These novel findings are paramount in that they identify a potential modifiable risk factor to improve outcomes after pediatric cardiac surgery with CPB. Additionally, low IgG is accompanied by fluid overload and prolonged mechanical ventilation. Igs constitute an important component of plasma oncotic pressure, so hypogammaglobulinemia may exacerbate anasarca, prolonging postoperative convalescence and increasing the morbidities associated with increased ICU length of stay.9
Igs have an increasingly recognized role in modulating the innate immune response. Present use of IVIG exceeds mere antibody replacement and extends to the treatment of autoimmune and inflammatory conditions. In fact, more than 75% of IVIG use in the U.S. today is for the treatment of inflammatory conditions, where proposed mechanisms include reduction of pro-inflammatory cytokine and adhesion molecule expression, superantigen neutralization, restoration of glucocorticoid responsiveness, and blockade of complement fragment deposition. It is plausible that IVIG could benefit neonates after cardiac surgery not only via restoration of humoral opsonization capacity, but also as a modulator of innate immunity and SIRS. According to this model, tissue injury, CPB, and shock trigger SIRS, leading to hypogammaglobulinemia and resultant increased susceptibility to inflammatory dysregulation which might be ameliorated via administration of IVIG.
In an adult study, IVIG failed to benefit postoperative cardiac patients with severe SIRS. However, the dose of IVIG given was relatively small compared with that typically given for autoimmune and inflammatory conditions. Neonates and infants may be more susceptible to the harmful effects of acquired hypogammaglobulinemia than adults as they may be unable to generate adequate quantities of antibodies in response to pathogens, relying mainly on maternal Igs until around the 4th to 6th month of life. In addition, they display an exaggerated inflammatory response to CPB as compared with older children and adults, so they might stand to benefit more from IVIG as an immunomodulator.
Because of the increased vulnerability to acquired infection and other morbidities in the setting of hypogammaglobulinemia as result of enhanced SIRS and immune dysfunction, it is feasible that normalization of IgG concentration in the neonatal and infant population may improve clinical outcomes via restoration of the humoral immune system, modulation of the innate immune system, and restoration of intravascular oncotic pressure. The appropriate IgG level threshold for treatment and optimal plasma IgG level to target after administration of IVIG are presently unknown.
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 |
|---|---|---|
| IVIG | Experimental | Drug: IVIGThose randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose and will be administered per hospital standards for IVIG administration. |
| Normal Saline | Placebo comparator | Other: PlaceboSubject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. This infusion will be administered as if the subject is receiving IVIG according to hospital policy. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants <6 months old
- Successfully weaned off cardiopulmonary bypass after cardiac surgery
Key exclusion criteria (5 listed)
- Requirement of extra corporeal membrane oxygenation in the operating room
- Known immune deficiency
- Current Do Not Resuscitate or limitation of care order
- Current enrollment in another interventional clinical study
- Refusal of parental 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 |
|---|---|---|
| IVIGAlso: GamunexThose randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care. | Drug | IVIG |
| PlaceboAlso: Normal SalineIf the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight. | Other | Normal Saline |
Primary outcome
Post-Operative Infections
Time frame: until Hospital Discharge, an average of 30 days
The primary endpoint of this study is incidence of post-operative infections through hospital discharge
Post-operative Infection
Time frame: within 1 week of surgery
Any positive culture or treatment for culture negative sepsis within 1 week of surgery
Blood Stream Infection
Time frame: until Hospital Discharge, an average of 30 days
Any positive blood culture during the post-operative period until hospital discharge
Blood Stream Infection Within 1 Week of Surgery
Time frame: 7 days
22 secondary outcomes
Post-operative Plasma Albumin
Time frame: up to 48 hours post CPB
Fluid Overload Variables
Time frame: 0-24 hours post-CPB
Post-operative Inotrope Score
Time frame: first 48 hours post-CPB
Respiratory Variables
Time frame: until Hospital Discharge, an average of 30 days
Hospital Discharge
Time frame: Approximately 1 month
Plasma Immunoglobulins
Time frame: 5 days post-op
Interferon-gamma Plasma Cytokine Levels
Time frame: Pre-operative to 48 hours post-operative
Immunoglobulin Concentration in Chest Tube Drainage
Time frame: 24 hours post-op
Mortality
Time frame: Approximately 1 month
Intensive Care Unit Length of Stay
Time frame: 1 month
Fluid Overload Variables
Time frame: 0-48 hours post-CPB
Respiratory Variables
Time frame: until extubation, an average of 2 days
Respiratory Variables
Time frame: until extubation, an average of 2 days
Interleukin-10 Plasma Cytokine Levels
Time frame: pre-operative through 48 hours post-operative
Interleukin-12p70 Plasma Cytokine Levels
Time frame: pre-operative through 48 hours post-operative
Interleukin-1b Plasma Cytokine Levels
Time frame: pre-operative through 48 hours post-operative
Interleukin-6 Plasma Cytokine Levels
Time frame: pre-operative through 48 hours post-operative
Interleukin-8 Plasma Cytokine Levels
Time frame: pre-operative through 48 hours post-operative
Tumor Necrosis Factor Plasma Cytokine Levels
Time frame: pre-operative through 48 hours post-operative
Immunoglobulin Concentration in Peritoneal Dialysis Drainage
Time frame: 24 hours post-op
Serum Creatinine
Time frame: 48 hours
Lactic Acid
Time frame: pre-operative through 24 hours post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will not be shared with other individuals
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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.
Jeffrey Alten, MD principal investigator
University of Alabama at Birmingham Pediatric Cardiac Critical Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVIG in people with Hypogammaglobulinemia and Congenital Heart Disease, run by University of Alabama at Birmingham 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 2 inclusion and 5 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 13 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2017). 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?
Post-Operative Infections (time frame: until Hospital Discharge, an average of 30 days). The study lists 4 primary outcomes in all. 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 13 Apr 2017.