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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Cukurova University

    Adana, 01330

Other trials in Turkey (Türkiye)

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.

Being tested
Sevoflurane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04254744
Study groupRoleWhat they receive
Acyanotic childrenAcyanotic children undergoing cardiac surgery due to congenital heart disease
Receives: Drug: Sevoflurane
Cyanotic childrenCyanotic 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.

  1. White blood cell count

    Measured: 48 hours after arrival in Intensive care unit

  2. body temperature

    Measured: 48 hours after arrival in Intensive care unit

  3. 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.

  1. First posted5 Feb 2020
  2. Study start4 Feb 2020
  3. Primary completion4 Jan 2021
  4. Study completion4 Feb 2021

Resources

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
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

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.

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