Trial Outcomes & Findings for Renal Perfusion, Filtration and Oxygenation During Cardiopulmonary Bypass (CPB) (NCT NCT02405195)

NCT ID: NCT02405195

Last Updated: 2019-05-07

Results Overview

Renal blood flow measured with PAH clearance

• Recruitment status: COMPLETED
• Target enrollment: 28 participants
• Primary outcome timeframe: 6 hours
• Results posted on: 2019-05-07

Participant Flow

Participant milestones

Measure	CardioPulmonaryBypass Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	CardioPulmonary Bypass n=18 Participants Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.
Age, Categorical <=18 years	0 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=18 Participants
Age, Categorical >=65 years	13 Participants n=18 Participants
Sex: Female, Male Female	2 Participants n=18 Participants
Sex: Female, Male Male	16 Participants n=18 Participants
Region of Enrollment Sweden	18 participants n=18 Participants
Serum creatinine	87 micromol per litre STANDARD_DEVIATION 11 • n=18 Participants
Left ventricular ejection fraction	58 % STANDARD_DEVIATION 5 • n=18 Participants

PRIMARY outcome

Timeframe: 6 hours

Renal blood flow measured with PAH clearance

Outcome measures

Measure	CardioPulmonaryBypass n=18 Participants Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.
Renal Blood Flow (RBF) Pre CPB	554 ml per minute per 1.73 m2 body surface Standard Deviation 126
Renal Blood Flow (RBF) CPB 30 minutes	524 ml per minute per 1.73 m2 body surface Standard Deviation 116
Renal Blood Flow (RBF) CPB 60 minutes	564 ml per minute per 1.73 m2 body surface Standard Deviation 162
Renal Blood Flow (RBF) Post CPB (30 - 60 minutes)	558 ml per minute per 1.73 m2 body surface Standard Deviation 130

PRIMARY outcome

Timeframe: 6 hours

GFR measured by renal extraction of 51Cr-EDTA

Outcome measures

Measure	CardioPulmonaryBypass n=18 Participants Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.
Glomerular Filtration Rate (GFR) Before CPB	67 ml per minute per 1.73 m2 body surface Standard Deviation 23
Glomerular Filtration Rate (GFR) CPB 30 minutes	68 ml per minute per 1.73 m2 body surface Standard Deviation 23
Glomerular Filtration Rate (GFR) CPB 60 minutes	70 ml per minute per 1.73 m2 body surface Standard Deviation 19
Glomerular Filtration Rate (GFR) Post CPB (30 - 60 minutes)	67 ml per minute per 1.73 m2 body surface Standard Deviation 18

PRIMARY outcome

Timeframe: 6 hours

Renal oxygen extraction, defined as renal oxygen consumption divided by renal oxygen delivery

Outcome measures

Measure	CardioPulmonaryBypass n=18 Participants Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.
Renal Oxygenation CPB 60 minutes	0.13 fraction Standard Deviation 0.06
Renal Oxygenation Pre CPB	0.09 fraction Standard Deviation 0.03
Renal Oxygenation CPB 30 minutes	0.12 fraction Standard Deviation 0.05
Renal Oxygenation Post CPB (30 - 60 minutes)	0.16 fraction Standard Deviation 0.05

SECONDARY outcome

Timeframe: 24 hours

Urinary biomarker of tubular renal injury

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

AKI according to AKIN criteria

Outcome measures

Outcome data not reported

Adverse Events

CardioPulmonaryBypass

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CardioPulmonaryBypass n=18 participants at risk Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2.
Renal and urinary disorders Acute kidney injury	22.2% 4/18 • Number of events 4 • Three days Postoperative acute kidney injury, defined as an increase in serum-creatinine ≥50 % from baseline.

Additional Information

Lukas Lannemyr

Västra Götalandsregionen

Phone: 46313428860

Email: lukas.lannemyr@vgregion.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place