An observational study in Aortic Coarctation and Cardiac Output, Low, sponsored by Konya City Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged Up to 3 Months. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Konya City Hospital · Observational
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.
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.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's planned enrollment of 43 is below the median of 100 across 29 observational studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →Konya City Hospital is the lead sponsor of 81 studies on the registry; 23 are open to participants now.
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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.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: MostCare (PRAM) · Device: Near-Infrared Spectroscopy (NIRS) · Procedure: Arterial Blood Gas with Lactate
Real-time, calibration-free cardiac index monitoring via arterial pressure waveform analysis using the MostCare™ system. Used as part of routine intraoperative hemodynamic monitoring.
Also known as: Pressure Recording Analytical Method
Non-invasive monitoring of regional cerebral and renal oxygen saturation (rSO2) using the INVOS™ oximeter as part of standard intraoperative care.
Also known as: INVOS Oximeter
Arterial blood gas sampling for lactate measurement at four intraoperative time points as part of routine clinical monitoring.
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.
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 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.
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
Pearson or Spearman correlation coefficient between cardiac index (CI, L/min/m²) and arterial lactate level (mmol/L) at four intraoperative time points.
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)
Plan to share: No
Start is estimated for May 2026; primary completion for Dec 2026, 7 months later.
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Konya City Hospital