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NCT Number: NCT07568431

Correlation of Cardiac Index Measured by the PRAM Method With NIRS and Lactate Levels in Pediatric Aortic Coarctation Surgery

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.

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Key information

Conditions

Aortic Coarctation Cardiac Output, Low Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

SBÜ Konya Şehir Hastanesi

Konya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MostCare (PRAM)

Device

Real-time, calibration-free cardiac index monitoring via arterial pressure waveform analysis using the MostCare™ system. Used as part of routine intraoperative hemodynamic monitoring.

Other names: Pressure Recording Analytical Method

Near-infrared spectroscopy (NIRS)

Device

Non-invasive monitoring of regional cerebral and renal oxygen saturation (rSO2) using the INVOS™ oximeter as part of standard intraoperative care.

Other names: INVOS Oximeter

Arterial Blood Gas with Lactate

Procedure

Arterial blood gas sampling for lactate measurement at four intraoperative time points as part of routine clinical monitoring.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    Pearson or Spearman correlation coefficient between cardiac index (CI, L/min/m²) and renal regional oxygen saturation (rSO2r, %) at four intraoperative time points.

  2. 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)

    Pearson or Spearman correlation coefficient between cardiac index (CI, L/min/m²) and arterial lactate level (mmol/L) at four intraoperative time points.

Study contacts

Contact information is provided by the study sponsor or research team.

Bedia Mine Hanedan, MD

CONTACT

[email protected]

+905059269595

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study 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

Acronym: MostCare-Ped

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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