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A study for the effect of new individualized hemodynamic management on postoperative outcomes in patients undergoing cardiac surgery

A study for the effect of new individualized hemodynamic management on postoperative outcomes in patients undergoing cardiac surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023066
Enrollment
Unknown
Registered
2019-05-09
Start date
2019-06-15
Completion date
Unknown
Last updated
2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart disease

Interventions

Control group:none
Experimental group:Tissue oxygen monitoring

Sponsors

Tianjin Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Adult patients = 50 years old; 2) Scheduled for isolated off-pump CABG with median sternotomy under general anesthesia with endotracheal intubation.

Exclusion criteria

Exclusion criteria: 1) Having a concomitant cardiac procedure associated with CABG; 2) Emergency CABG surgery (i.e., immediate revascularization for hemodynamic instability); 3) Redo CABG; 4) Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome; 5) Circulatory shock; 6) Preoperative sepsis; 7) Chronic kidney disease with glomerular filtration rate < 30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease; 8) Participation in another competing treatment study; 9) Refusal to participate; 10) Pregnant or breastfeeding women; 11) Muscular dystrophy or atrophy (with a potential to interfere with muscular tissue oxygen saturation monitoring); 12) Skin conditions incompatible with the adhesive oximetry probe.

Design outcomes

Primary

MeasureTime frame
systemic inflammatory response syndrome;at least 1 organ system injury or dysfunction occurring within day 7 after surgery;

Secondary

MeasureTime frame
changes in hemodynamic variables;individual components of the primary composite outcome;the SOFA score on days 1, 2, and 7;postoperative complications;durations of intensive care unit and hospital stay;all-cause mortality at 30 days after surgery;

Countries

China

Contacts

Public ContactJiange Han

Tianjin Chest Hospital

103844013@qq.com+86 13821001156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026