Aortic CoarctationMostCare-PedNCT07568431
Correlation of Cardiac Index Measured by the PRAM Method With NIRS and Lactate Levels in Pediatric Aortic Coarctation Surgery
An observational study of Aortic Coarctation and Cardiac Output, Low, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the correlation between cardiac index measured by the MostCare™ system (Pressure Recording Analytical Method, PRAM) and cerebral/renal regional oxygen saturation measured by near-infrared spectroscopy (NIRS) and arterial lactate levels in neonates and infants (body… Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Aortic Coarctation, Cardiac Output, Low
- What is being tested?
- MostCare (PRAM), Near-Infrared Spectroscopy (NIRS) and Arterial Blood Gas with Lactate
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Neonates and infants aged 0-3 months with body weight 2.5-3.5 kg diagnosed with aortic coarctation and scheduled for surgical repair at SBU Konya City Hospital, Konya, Turkey.
Who may be able to join
- Neonates and infants planned for surgical repair of aortic coarctation
- Body weight between 2.5 and 3.5 kg
- Postnatal age between 0 and 3 months
- Considered hemodynamically stable for anesthesia and surgery
- Written informed consent obtained from legal guardians
Who cannot join
- Severe multiorgan dysfunction
- Additional major congenital heart defect (e.g., Tetralogy of Fallot, Transposition of Great Arteries, Hypoplastic Left Heart Syndrome)
- Surgery requiring cardiopulmonary bypass
- Preoperative metabolic acidosis or sepsis
- Inability to obtain informed consent from legal guardians
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Correlation of Cardiac Index Measured by the Pressure Recording Analytical Method (PRAM) With Near-Infrared Spectroscopy (NIRS) and Arterial Lactate Levels in Neonates and Infants Undergoing Surgical Repair of Aortic Coarctation: A Prospective Observational Study
This prospective observational study aims to evaluate the correlation between cardiac index measured by the MostCare™ system (Pressure Recording Analytical Method, PRAM) and cerebral/renal regional oxygen saturation measured by near-infrared spectroscopy (NIRS) and arterial lactate levels in neonates and infants (body weight 2.5-3.5 kg, age 0-3 months) undergoing surgical repair of aortic coarctation. Measurements will be recorded at four intraoperative time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery. No additional intervention beyond standard anesthesia and surgical care will be applied.
Read the detailed description
Low cardiac output syndrome (LCOS) is a major determinant of postoperative morbidity and mortality in neonatal cardiac surgery, particularly in lesions affecting systemic circulation such as aortic coarctation. Reliable intraoperative assessment of cardiac output is therefore critical in this patient population.
The MostCare™ system uses the Pressure Recording Analytical Method (PRAM) to provide real-time, calibration-free cardiac index (CI) measurement derived solely from the arterial pressure waveform. Previous studies in infants have demonstrated good correlation between PRAM and echocardiography; however, data in neonates weighing less than 3.5 kg remain very limited.
Near-infrared spectroscopy (NIRS) allows non-invasive monitoring of regional cerebral and renal oxygen saturation (rSO2), serving as an early indicator of tissue oxygenation. Arterial lactate is a biochemical marker of cellular hypoperfusion and is strongly associated with postoperative outcomes.
In this study, CI (MostCare™), cerebral and renal NIRS (INVOS™ oximeter), and arterial lactate will be simultaneously recorded at four intraoperative time points in neonates and infants undergoing aortic coarctation repair. The primary aim is to assess the correlation between PRAM-derived CI and cerebral NIRS. Secondary aims include the correlation between CI and renal NIRS, and between CI and arterial lactate levels.
- Conditions
- Aortic Coarctation, Cardiac Output, Low
- Being tested
- MostCare (PRAM), Near-Infrared Spectroscopy (NIRS), Arterial Blood Gas with Lactate
- Keywords
- PRAM, Near-Infrared Spectroscopy, Cardiac Index, Pediatric Cardiac Surgery, Lactate, Aortic Coarctation
- Medical subject headings
- Aortic Coarctation, Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MostCare (PRAM)Device
Also called Pressure Recording Analytical Method
Real-time, calibration-free cardiac index monitoring via arterial pressure waveform analysis using the MostCare™ system. Used as part of routine intraoperative hemodynamic monitoring.
Near-Infrared Spectroscopy (NIRS)Device
Also called INVOS Oximeter
Non-invasive monitoring of regional cerebral and renal oxygen saturation (rSO2) using the INVOS™ oximeter as part of standard intraoperative care.
Arterial Blood Gas with LactateProcedure or surgery
Arterial blood gas sampling for lactate measurement at four intraoperative time points as part of routine clinical monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Aortic Coarctation Surgery Group | Neonates and infants aged 0-3 months with body weight 2.5-3.5 kg undergoing surgical repair of aortic coarctation. Cardiac index (MostCare™/PRAM), cerebral and renal NIRS (INVOS™), and arterial lactate levels are recorded at four intraoperative time points under standard anesthesia protocol. Receives: Device: MostCare (PRAM); Device: Near-Infrared Spectroscopy (NIRS); Procedure: Arterial Blood Gas with Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between PRAM-derived Cardiac Index and Cerebral NIRS (rSO2c)
Pearson or Spearman correlation coefficient between cardiac index (CI, L/min/m²) measured by MostCare™ (PRAM method) and cerebral regional oxygen saturation (rSO2c, %) measured by INVOS™ oximeter at four intraoperative time points.
Measured: Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery)
Secondary outcomes (2)
Correlation between PRAM-derived Cardiac Index and Renal NIRS (rSO2r)
Pearson or Spearman correlation coefficient between cardiac index (CI, L/min/m²) and renal regional oxygen saturation (rSO2r, %) at four intraoperative time points.
Measured: Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery)
Correlation between PRAM-derived Cardiac Index and Arterial Lactate Level
Pearson or Spearman correlation coefficient between cardiac index (CI, L/min/m²) and arterial lactate level (mmol/L) at four intraoperative time points.
Measured: Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aortic CoarctationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BEDİA MİNE HANEDAN, Konya City Hospital
- Investigators
- Bedia Mine Hanedan, MD, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568431
- Sponsor's protocol ID
- 828-828-17
- Acronym
- MostCare-Ped
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Viguera AC, Cohen LS, Baldessarini RJ, Nonacs R. Managing bipolar disorder during pregnancy: weighing the risks and benefits. Can J Psychiatry. 2002 Jun;47(5):426-36. doi: 10.1177/070674370204700503.
PubMed 12085677Zaleski KL, Kussman BD. Near-Infrared Spectroscopy in Pediatric Congenital Heart Disease. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):489-500. doi: 10.1053/j.jvca.2019.08.048. Epub 2019 Sep 3.
PubMed 31582201Francis NK, Curtis NJ, Conti JA, Foster JD, Bonjer HJ, Hanna GB; EAES committees. EAES classification of intraoperative adverse events in laparoscopic surgery. Surg Endosc. 2018 Sep;32(9):3822-3829. doi: 10.1007/s00464-018-6108-1. Epub 2018 Feb 12.
PubMed 29435754Itzcovich T, Xi Z, Martinetto H, Chrem-Mendez P, Russo MJ, de Ambrosi B, Uchitel OD, Nogues M, Silva E, Rojas G, Bagnatti P, Amengual A, Campos J, Rogaeva E, St George-Hyslop P, Allegri R, Sevlever G, Surace EI. Analysis of C9orf72 in patients with frontotemporal dementia and amyotrophic lateral sclerosis from Argentina. Neurobiol Aging. 2016 Apr;40:192.e13-192.e15. doi: 10.1016/j.neurobiolaging.2016.02.001. Epub 2016 Feb 6.
PubMed 26925510Galyfos G, Sigala F, Aggeli K, Filis K. Re: 'long-term results of a randomized controlled trial analyzing the role of systematic pre-operative coronary angiography before elective carotid endarterectomy in patients with asymptomatic coronary artery disease'. Eur J Vasc Endovasc Surg. 2015 Aug;50(2):263-4. doi: 10.1016/j.ejvs.2015.04.020. Epub 2015 May 20. No abstract available.
PubMed 26001321
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Cardiac Index Measured by the Pressure Recording Analytical Method (PRAM) With Near-Infrared Spectroscopy (NIRS) and Arterial Lactate Levels in Neonates and Infants Undergoing Surgical Repair of Aortic Coarctation: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07568431
- Acronym / sponsor ID
- MostCare-Ped / 828-828-17
- Conditions
- Aortic Coarctation, Cardiac Output, Low
- Keywords
- PRAM, Near-Infrared Spectroscopy, Cardiac Index, Pediatric Cardiac Surgery, Lactate, Aortic Coarctation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 May 2026 (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.
This prospective observational study aims to evaluate the correlation between cardiac index measured by the MostCare™ system (Pressure Recording Analytical Method, PRAM) and cerebral/renal regional oxygen saturation measured by near-infrared spectroscopy (NIRS) and arterial lactate levels in neonates and infants (body weight 2.5-3.5 kg, age 0-3 months) undergoing surgical repair of aortic coarctation. Measurements will be recorded at four intraoperative time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery. No additional intervention beyond standard anesthesia and surgical care will be applied.
Detailed description
Low cardiac output syndrome (LCOS) is a major determinant of postoperative morbidity and mortality in neonatal cardiac surgery, particularly in lesions affecting systemic circulation such as aortic coarctation. Reliable intraoperative assessment of cardiac output is therefore critical in this patient population.
The MostCare™ system uses the Pressure Recording Analytical Method (PRAM) to provide real-time, calibration-free cardiac index (CI) measurement derived solely from the arterial pressure waveform. Previous studies in infants have demonstrated good correlation between PRAM and echocardiography; however, data in neonates weighing less than 3.5 kg remain very limited.
Near-infrared spectroscopy (NIRS) allows non-invasive monitoring of regional cerebral and renal oxygen saturation (rSO2), serving as an early indicator of tissue oxygenation. Arterial lactate is a biochemical marker of cellular hypoperfusion and is strongly associated with postoperative outcomes.
In this study, CI (MostCare™), cerebral and renal NIRS (INVOS™ oximeter), and arterial lactate will be simultaneously recorded at four intraoperative time points in neonates and infants undergoing aortic coarctation repair. The primary aim is to assess the correlation between PRAM-derived CI and cerebral NIRS. Secondary aims include the correlation between CI and renal NIRS, and between CI and arterial lactate levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic Coarctation Surgery Group | – | Device: MostCare (PRAM), Device: Near-Infrared Spectroscopy (NIRS), Procedure: Arterial Blood Gas with LactateNeonates and infants aged 0-3 months with body weight 2.5-3.5 kg undergoing surgical repair of aortic coarctation. Cardiac index (MostCare™/PRAM), cerebral and renal NIRS (INVOS™), and arterial lactate levels are recorded at four intraoperative time points under standard anesthesia protocol. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates and infants aged 0-3 months with body weight 2.5-3.5 kg diagnosed with aortic coarctation and scheduled for surgical repair at SBU Konya City Hospital, Konya, Turkey.
Key inclusion criteria (5 listed)
- Neonates and infants planned for surgical repair of aortic coarctation
- Body weight between 2.5 and 3.5 kg
- Postnatal age between 0 and 3 months
- Considered hemodynamically stable for anesthesia and surgery
- Written informed consent obtained from legal guardians
Key exclusion criteria (5 listed)
- Severe multiorgan dysfunction
- Additional major congenital heart defect (e.g., Tetralogy of Fallot, Transposition of Great Arteries, Hypoplastic Left Heart Syndrome)
- Surgery requiring cardiopulmonary bypass
- Preoperative metabolic acidosis or sepsis
- Inability to obtain informed consent from legal guardians
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 |
|---|---|---|
| MostCare (PRAM)Also: Pressure Recording Analytical MethodReal-time, calibration-free cardiac index monitoring via arterial pressure waveform analysis using the MostCare™ system. Used as part of routine intraoperative hemodynamic monitoring. | Device | Aortic Coarctation Surgery Group |
| Near-Infrared Spectroscopy (NIRS)Also: INVOS OximeterNon-invasive monitoring of regional cerebral and renal oxygen saturation (rSO2) using the INVOS™ oximeter as part of standard intraoperative care. | Device | Aortic Coarctation Surgery Group |
| Arterial Blood Gas with LactateArterial blood gas sampling for lactate measurement at four intraoperative time points as part of routine clinical monitoring. | Procedure or surgery | Aortic Coarctation Surgery Group |
Primary outcome
Correlation between PRAM-derived Cardiac Index and Cerebral NIRS (rSO2c)
Time frame: Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery)
Pearson or Spearman correlation coefficient between cardiac index (CI, L/min/m²) measured by MostCare™ (PRAM method) and cerebral regional oxygen saturation (rSO2c, %) measured by INVOS™ oximeter at four intraoperative time points.
2 secondary outcomes
Correlation between PRAM-derived Cardiac Index and Renal NIRS (rSO2r)
Time frame: Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery)
Correlation between PRAM-derived Cardiac Index and Arterial Lactate Level
Time frame: Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 12085677Viguera AC, Cohen LS, Baldessarini RJ, Nonacs R. Managing bipolar disorder during pregnancy: weighing the risks and benefits. Can J Psychiatry. 2002 Jun;47(5):426-36. doi: 10.1177/070674370204700503.
- Background: PubMed 31582201Zaleski KL, Kussman BD. Near-Infrared Spectroscopy in Pediatric Congenital Heart Disease. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):489-500. doi: 10.1053/j.jvca.2019.08.048. Epub 2019 Sep 3.
- Background: PubMed 29435754Francis NK, Curtis NJ, Conti JA, Foster JD, Bonjer HJ, Hanna GB; EAES committees. EAES classification of intraoperative adverse events in laparoscopic surgery. Surg Endosc. 2018 Sep;32(9):3822-3829. doi: 10.1007/s00464-018-6108-1. Epub 2018 Feb 12.
- Background: PubMed 26925510Itzcovich T, Xi Z, Martinetto H, Chrem-Mendez P, Russo MJ, de Ambrosi B, Uchitel OD, Nogues M, Silva E, Rojas G, Bagnatti P, Amengual A, Campos J, Rogaeva E, St George-Hyslop P, Allegri R, Sevlever G, Surace EI. Analysis of C9orf72 in patients with frontotemporal dementia and amyotrophic lateral sclerosis from Argentina. Neurobiol Aging. 2016 Apr;40:192.e13-192.e15. doi: 10.1016/j.neurobiolaging.2016.02.001. Epub 2016 Feb 6.
- Background: PubMed 26001321Galyfos G, Sigala F, Aggeli K, Filis K. Re: 'long-term results of a randomized controlled trial analyzing the role of systematic pre-operative coronary angiography before elective carotid endarterectomy in patients with asymptomatic coronary artery disease'. Eur J Vasc Endovasc Surg. 2015 Aug;50(2):263-4. doi: 10.1016/j.ejvs.2015.04.020. Epub 2015 May 20. No abstract available.
- 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.
Bedia Mine Hanedan, MD principal investigator
Konya City Hospital
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 Aortic Coarctation and Cardiac Output, Low, run by Konya City Hospital 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 5 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: opening soon, as of the sponsor's last update on 5 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bedia Mine Hanedan, MD (+905059269595, bediaminech@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between PRAM-derived Cardiac Index and Cerebral NIRS (rSO2c) (time frame: Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery)). 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 NCT07568431, which also lists 5 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 5 May 2026.