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

Acute Kidney Injury Clinical Trial

— HYDRATE-CSX  

Official title:

Influence of Preoperative Fluid Intake on the Onset of Postoperative Acute Kidney Injury in Cardiac Surgery Patients: the HYDRATE-CSX Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03938181
• Other study ID #: 3CARE_BOÄ_18-004_Hydrate-CSX
• Status: Recruiting
• Start date: April 23, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: September 2019
• Source: RWTH Aachen University
• Contact: Julia Krieger
• Phone: +49 241 88726
• Email: jukrieger[@]ukaachen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: March 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Care
• Thoracic Surgery
• Wounds and Injuries

Locations

Country	Name	City	State
Germany	University Hospital RWTH Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute kidney injury	Acute kidney injury	30 days
Primary	Renal replacement therapy	Renal replacement therapy	7 days postoperative
Primary	Kidney-failure-free days	defined as the number of days in which a patient had no acute kidney injury and no need for RRT	7 days postoperative
Secondary	Major Adverse Kidney Events	death, dialysis or persistent renal dysfunction	30 days
Secondary	Fluid intake since hospital admission until surgery (ml/h)	Fluid intake since hospital admission until surgery (ml/h)	30 days
Secondary	Calorie intake since hospital admission (kcal/d)	Calorie intake since hospital admission (kcal/d)	30 days
Secondary	Preoperative abstinence of fluids (minutes)	Preoperative abstinence of fluids (minutes)	30 days
Secondary	Preoperative abstinence of food (minutes)	Preoperative abstinence of food (minutes)	30 days
Secondary	ICU length of stay (hours)	ICU length of stay (hours)	30 days
Secondary	Hospital length of stay since surgery (days)	Hospital length of stay since surgery (days)	30 days
Secondary	Mortality until hospital discharge/ 30 days	Mortality until hospital discharge/ 30 days	up to 30 days