Influence of Preoperative Fluid Intake on the Onset of Postoperative Acute Kidney Injury

• Conditions: Acute Kidney Injury; Critical Care; Thoracic Surgery

• Registration Number: NCT03938181
• Lead Sponsor: RWTH Aachen University

Brief Summary

To investigate the influence of preoperative fluid and food intake in cardiac surgery patients on the development of postoperative AKI.

Detailed Description

Acute renal failure (ARF) and the need for renal replacement therapy (RRT) is a major complication after cardiac surgery, associated with mortality and an increased risk to develop end-stage renal disease. Cardiac surgery patients are at increased risk to develop acute kidney failure due to ischaemia-reperfusion injury, cardiopulmonary bypass (CPB) induced inflammation and haemolysis, hemodynamic alterations, vasoconstriction and resulting reduced renal perfusion. According to the current literature, AKI occurs in average in 20-30% after cardiac surgery with an incidence of RRT in 1-5%. Several reviews revealed the literature and concluded that , inter alia, euvolemia, adequate nutrition, the avoidance of nephrotoxic drugs and anemia optimization belong to the most effective prevention strategies.

Patients are instructed to follow the nil per os (NPO) guidelines, including abstinence of clear liquids for \>2 hours preoperative as well as fasting time of light foods for \> 6 hours and fatty foods for \>8 hours prior to surgery. However, these guidelines encourage patients to continue PO hydration until 2 h before surgery in order to optimize the volume status. Besides the fact that NPO lasts in average critically longer than required, surgery delay is a common issue and may lead to an exceedance of NPO up to twice as long as required.

Data about the exact mechanism is still sparse, but preoperative iv hydration may correct or even expand intravascular volume, improve renal perfusion and induce diuresis, stimulate endogenous natriuretic peptides release and inactivate the renin-angiotensin-aldosterone system (RAAS).

Large trials on this very relevant topic in these high risk cardiac surgery patients are absolutely missing. Therefore, this prospective observational study aims to investigate the influence of varied preoperative fluid and food intake in cardiac surgery patients on the development of postoperative AKI.

Study Timeline

• Study Start: 2019-04-23
• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11
• Primary Completion: 2020-01-15
• Study Completion: 2020-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Adult patients (>18 years of age) scheduled to undergo elective cardiac surgery with the use of cardiopulmonary bypass (CPB) and cardioplegic arrest

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Exclusion Criteria

• Patients not willing to participate or not able to give informed consent
• Patients receiving contrast agents within 72 hours before surgery
• Patients with preoperative need for renal replacement therapy
• Patients receiving an extracorporeal mechanical assist device (e.g. ECLS) or for advanced heart failure therapies (e.g. TAH, VAD) will be excluded.
• Patients participating in another interventional trial
• Pregnant or lactating patients

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kidney-failure-free days	7 days postoperative	defined as the number of days in which a patient had no acute kidney injury and no need for RRT
Acute kidney injury	30 days	Acute kidney injury
Renal replacement therapy	7 days postoperative	Renal replacement therapy

Secondary Outcome Measures

Name	Time	Method
Mortality until hospital discharge/ 30 days	up to 30 days	Mortality until hospital discharge/ 30 days
Preoperative abstinence of food (minutes)	30 days	Preoperative abstinence of food (minutes)
Fluid intake since hospital admission until surgery (ml/h)	30 days	Fluid intake since hospital admission until surgery (ml/h)
Calorie intake since hospital admission (kcal/d)	30 days	Calorie intake since hospital admission (kcal/d)
Hospital length of stay since surgery (days)	30 days	Hospital length of stay since surgery (days)
ICU length of stay (hours)	30 days	ICU length of stay (hours)
Major Adverse Kidney Events	30 days	death, dialysis or persistent renal dysfunction
Preoperative abstinence of fluids (minutes)	30 days	Preoperative abstinence of fluids (minutes)

Trial Locations

Locations (1)

University Hospital RWTH Aachen; 🇩🇪 Aachen, NRW, Germany