SIRSSIRSNCT04254744
SIRS in Cyanotic and Acyanotic Children in Cardiac Surgery
An observational study of SIRS and Pediatric Cardiac Surgery, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Systemic inflammatory response syndrome (SIRS) is frequently observed in children after open-heart surgery and has been associated with both cardiopulmonary bypass and surgical trauma. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- SIRS, Pediatric Cardiac Surgery
- What is being tested?
- Sevoflurane
- How many people
- 197 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Feb 2020to 4 Feb 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients with congenital heart disease
Who may be able to join
- Patients aged between 0-16 years
- undergoing open heart surgery for cyanotic and acyanotic congenital heart disease
Who cannot join
- Patients with preoperative renal failure
- Patients with preoperative hepatic disease
- Patients with preoperative inflammatory disease
- Patients using anti-inflammatory drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Inflammatory Response Syndrome Cyanotic and Acyanotic Children Undergoing Cardiac Surgery
Systemic inflammatory response syndrome (SIRS) is frequently observed in children after open-heart surgery and has been associated with both cardiopulmonary bypass and surgical trauma. Children with congenital cyanotic heart disease (CCHD) have complex changes in all blood values and clotting profiles due to chronic hypoxemia. Increased erythrocyte count decreases plasma and coagulation factors, platelet count and function. Therefore, blood and blood products transfusion may increase during intraoperative and postoperative periods. In addition, durations of cardiopulmonary bypass may prolong due to the complex defects of children with CCHD. The aim of this study is to investigate postoperative SIRS rates and risk factors in cyanotic and acyanotic children undergoing open heart surgery for congenital heart disease.
Read the detailed description
Systemic inflammatory response syndrome (SIRS) in adults has been defined as a non-specific systemic inflammatory process in the absence of infection, following incidents such as trauma, burns, pancreatitis, or major surgery. For children, age-specific SIRS criteria were established by the International Pediatric Sepsis Consensus Conference in 2005. SIRS was defined as presence of at least two out of four parameters, one of which must be an abnormal temperature or leukocyte count. The two other criteria consist of either an elevated heart rate or respiratory rate. SIRS is frequently observed in children after open-heart surgery and has been associated with both cardiopulmonary bypass and surgical trauma. Following cardiac surgery the pathophysiological mechanisms of SIRS involve a cytokine-mediated general capillary leakage followed by intravascular volume depletion, generalized edema, circulatory compromise, and altered microcirculation. The inflammatory process may further impair the function of the lung, myocardium, kidney, liver, intestine, and brain.
Children with congenital cyanotic heart disease (CCHD) have complex changes in all blood values and clotting profiles due to chronic hypoxemia. Increased erythrocyte count decreases plasma and coagulation factors, platelet count and function. Therefore, blood and blood products transfusion may increase during intraoperative and postoperative periods. In addition, durations of cardiopulmonary bypass may prolong due to the complex defects of children with CCHD. Previous studies have reported that the duration of CPB and the amount of fresh frozen plasma transfusion increase SIRS formation.
The aim of this study is to investigate postoperative SIRS rates and risk factors in cyanotic and acyanotic children undergoing open heart surgery for congenital heart disease.
Patients aged between 0-16 years and undergoing open heart surgery for cyanotic and acyanotic congenital heart disease will be included in the study. Patients with preoperative renal failure or hepatic disease will be excluded. Patient's age, weight, comorbidities, details of previous operation will be recorded. Preoperative hematocrit value, white blood cell and platelet counts, biochemical parameters (blood urea nitrogen, creatinine, electrolyte values), diagnosis of CCHD, RACHS1 (risk adjustment for surgery for congenital heart disease) will be recorded. In intraoperative period; operation time, CPB time, aortic cross-clamp time, circulatory arrest time, body temperature and lowest body temperature reached during CPB, cardioplegia amount, The ACT (activated coagulation time), urine amount will be recorded. Intraoperative blood gas values, lactate, mean arterial pressure, glucose values will be recorded at 30 min intervals. The amount of crystalloid and colloid, erythrocyte, fresh frozen plasma, platelet and cryoprecipitate used in intraoperative period will be recorded. Heparin and protamine doses administered will be recorded. Vasoactive agents (dopamine, dobutamine, adrenaline, nitroglycerine) used in intraoperative period will be recorded.
During the postoperative intensive care period; arterial blood gases and lactate, hematocrit, liquid (crystalloid and colloid) and blood products administered will be monitored at 6th, 24th and 48th hours. The vasoactive agents used, the inotropic score, the amount of urine and the use of diuretics will be recorded. Length of stay ICU, duration of mechanical ventilation, length of stay hospital will be recorded.
Diagnosis of SIRS; in the postoperative period, the age-specific SIRS criteria determined by the International Pediatric Sepsis Consensus Conference will be used. Patients will be evaluated for the diagnosis of SIRS at postoperative 6th, 12th, 24th and 48th hours. SIRS rates and risk factors in cyanotic and acyanotic patients will be determined.
- Conditions
- SIRS, Pediatric Cardiac Surgery
- Being tested
- Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane inhalation for anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Acyanotic children | Acyanotic children undergoing cardiac surgery due to congenital heart disease Receives: Drug: Sevoflurane | |
| Cyanotic children | Cyanotic children undergoing cardiac surgery due to congenital heart disease Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
White blood cell count
Measured: 48 hours after arrival in Intensive care unit
body temperature
Measured: 48 hours after arrival in Intensive care unit
heart rate
Measured: 48 hours after arrival in Intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start4 Feb 2020
- Primary completion4 Jan 2021
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SIRSStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feride Karacaer, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254744
- Sponsor's protocol ID
- SIRS, cardiac surgery
- Acronym
- SIRS
- Status last verified
- Mar 2021
- First submitted
- 28 Oct 2019
- Last updated
- 15 Mar 2021
- Results posted
- 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 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Inflammatory Response Syndrome Cyanotic and Acyanotic Children Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04254744
- Acronym / sponsor ID
- SIRS / SIRS, cardiac surgery
- Conditions
- SIRS, Pediatric Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 4 Jan 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 5 Feb 2020 (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.
Systemic inflammatory response syndrome (SIRS) is frequently observed in children after open-heart surgery and has been associated with both cardiopulmonary bypass and surgical trauma. Children with congenital cyanotic heart disease (CCHD) have complex changes in all blood values and clotting profiles due to chronic hypoxemia. Increased erythrocyte count decreases plasma and coagulation factors, platelet count and function. Therefore, blood and blood products transfusion may increase during intraoperative and postoperative periods. In addition, durations of cardiopulmonary bypass may prolong due to the complex defects of children with CCHD. The aim of this study is to investigate postoperative SIRS rates and risk factors in cyanotic and acyanotic children undergoing open heart surgery for congenital heart disease.
Detailed description
Systemic inflammatory response syndrome (SIRS) in adults has been defined as a non-specific systemic inflammatory process in the absence of infection, following incidents such as trauma, burns, pancreatitis, or major surgery. For children, age-specific SIRS criteria were established by the International Pediatric Sepsis Consensus Conference in 2005. SIRS was defined as presence of at least two out of four parameters, one of which must be an abnormal temperature or leukocyte count. The two other criteria consist of either an elevated heart rate or respiratory rate. SIRS is frequently observed in children after open-heart surgery and has been associated with both cardiopulmonary bypass and surgical trauma. Following cardiac surgery the pathophysiological mechanisms of SIRS involve a cytokine-mediated general capillary leakage followed by intravascular volume depletion, generalized edema, circulatory compromise, and altered microcirculation. The inflammatory process may further impair the function of the lung, myocardium, kidney, liver, intestine, and brain.
Children with congenital cyanotic heart disease (CCHD) have complex changes in all blood values and clotting profiles due to chronic hypoxemia. Increased erythrocyte count decreases plasma and coagulation factors, platelet count and function. Therefore, blood and blood products transfusion may increase during intraoperative and postoperative periods. In addition, durations of cardiopulmonary bypass may prolong due to the complex defects of children with CCHD. Previous studies have reported that the duration of CPB and the amount of fresh frozen plasma transfusion increase SIRS formation.
The aim of this study is to investigate postoperative SIRS rates and risk factors in cyanotic and acyanotic children undergoing open heart surgery for congenital heart disease.
Patients aged between 0-16 years and undergoing open heart surgery for cyanotic and acyanotic congenital heart disease will be included in the study. Patients with preoperative renal failure or hepatic disease will be excluded. Patient's age, weight, comorbidities, details of previous operation will be recorded. Preoperative hematocrit value, white blood cell and platelet counts, biochemical parameters (blood urea nitrogen, creatinine, electrolyte values), diagnosis of CCHD, RACHS1 (risk adjustment for surgery for congenital heart disease) will be recorded. In intraoperative period; operation time, CPB time, aortic cross-clamp time, circulatory arrest time, body temperature and lowest body temperature reached during CPB, cardioplegia amount, The ACT (activated coagulation time), urine amount will be recorded. Intraoperative blood gas values, lactate, mean arterial pressure, glucose values will be recorded at 30 min intervals. The amount of crystalloid and colloid, erythrocyte, fresh frozen plasma, platelet and cryoprecipitate used in intraoperative period will be recorded. Heparin and protamine doses administered will be recorded. Vasoactive agents (dopamine, dobutamine, adrenaline, nitroglycerine) used in intraoperative period will be recorded.
During the postoperative intensive care period; arterial blood gases and lactate, hematocrit, liquid (crystalloid and colloid) and blood products administered will be monitored at 6th, 24th and 48th hours. The vasoactive agents used, the inotropic score, the amount of urine and the use of diuretics will be recorded. Length of stay ICU, duration of mechanical ventilation, length of stay hospital will be recorded.
Diagnosis of SIRS; in the postoperative period, the age-specific SIRS criteria determined by the International Pediatric Sepsis Consensus Conference will be used. Patients will be evaluated for the diagnosis of SIRS at postoperative 6th, 12th, 24th and 48th hours. SIRS rates and risk factors in cyanotic and acyanotic patients will be determined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acyanotic children | – | Drug: SevofluraneAcyanotic children undergoing cardiac surgery due to congenital heart disease |
| Cyanotic children | – | Drug: SevofluraneCyanotic children undergoing cardiac surgery due to congenital heart disease |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients with congenital heart disease
Key inclusion criteria (2 listed)
- Patients aged between 0-16 years
- undergoing open heart surgery for cyanotic and acyanotic congenital heart disease
Key exclusion criteria (4 listed)
- Patients with preoperative renal failure
- Patients with preoperative hepatic disease
- Patients with preoperative inflammatory disease
- Patients using anti-inflammatory drug
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 |
|---|---|---|
| SevofluraneSevoflurane inhalation for anesthesia | Drug | Acyanotic children, Cyanotic children |
Primary outcome
White blood cell count
Time frame: 48 hours after arrival in Intensive care unit
body temperature
Time frame: 48 hours after arrival in Intensive care unit
heart rate
Time frame: 48 hours after arrival in Intensive care unit
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 15 Mar 2021.
- 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?
An observational study of SIRS and Pediatric Cardiac Surgery, run by Cukurova University at 1 site in Turkey (Türkiye).
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 4 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 15 Mar 2021. 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 Turkey (Türkiye). 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.
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?
White blood cell count (time frame: 48 hours after arrival in Intensive care unit). The study lists 3 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 15 Mar 2021.