Impact of CArdiopulmonary Bypass Flow on Renal Blood Flow, Function and OXygenation

NCT02549066 | Completed

• 1 other identifier: SahlgrenskaUHThoraxLL4
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac surgery with cardiopulmonary bypass (CPB), especially when oxygen delivery is low, is associated with acute kidney injury. Unpublished data shows that renal oxygen delivery is compromised during CPB due to low hematocrit and redistribution of blood flow away from the kidneys. We wish to study if increased CPB flow can improve renal oxygenation. Patients who develop cardiac failure after weaning from CPB will be treated as per our departments routine with the inotropic agent milrinone, and measurements will be made before and after treatment.

Conditions

Complication of Extracorporeal Circulation; Kidney Circulation Disorder; Renal Function Disorder

Keywords

cardiopulmonary bypass; renal blood flow; renal function; renal oxygenation

Outcome Measures

Primary Outcomes (1)

• Renal oxygenation

  Renal oxygen extraction measured as difference between arterial and renal vein blood oxygen content divided by arterial oxygen content.

  10 minutes

Secondary Outcomes (2)

• Renal oxygenation measured with Near InfraRed Spectroscopy (NIRS)

  10 minutes

• Filtration fraction

  10 minutes

Interventions

Increased cardiopulmonary bypass flow PROCEDURE

In randomized order, CPB flow will be adjusted to 2,4, 2,7 and 3,0 L/min/m2. After 10 minutes of steady conditions at each level, measurements will be made.

Milrinone DRUG

After weaning from CPB, patients with signs of cardiac failure (as defined below) will be given milrinone (0,04 mg/kg as a loading dose and 0,50 ug/kg/min as subsequent infusion). Measurements of systemic and renal variables will be made before and 30 minutes after the dose. Indication: Central venous pressure (CVP) ≥ 12 mmHg AND/OR Pulmonary Capillary Wedge Pressure (PCWP) ≥ 16 mmHg AND Cardiac Index (CI) ≤ 2,1 L/min/m2 AND Pulse Pressure Variation (PPV) \< 12 %.

Also known as: Inotrope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Scheduled cardiac surgery (Coronary Artery Bypass Grafting or Valve Replacement)
• Normothermia during cardiopulmonary bypass
• Normal preoperative serum creatinine (in men; 60-105 umol/L, in women 45-90 umol/L)

You may not qualify if:

• Left ventricular ejection fraction \< 50%
• Body mass index \> 32 kg/m2
• Previous cerebrovascular lesion
• Radiocontrast allergy

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Department of thoracic anesthesia, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (1)

• Lannemyr L, Bragadottir G, Redfors B, Ricksten SE. Effects of milrinone on renal perfusion, filtration and oxygenation in patients with acute heart failure and low cardiac output early after cardiac surgery. J Crit Care. 2020 Jun;57:225-230. doi: 10.1016/j.jcrc.2019.12.022. Epub 2020 Jan 6.

  PMID: 31919012 DERIVED

MeSH Terms

Interventions

Milrinone

Intervention Hierarchy (Ancestors)

Amrinone; Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M D

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 14, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)