Influence of Preoperative Fluid Intake on the Onset of Postoperative Acute Kidney Injury (HYDRATE-CSX)
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|ClinicalTrials.gov Identifier: NCT03938181|
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
|Condition or disease|
|Thoracic Surgery Acute Kidney Injury Critical Care|
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 Type :||Observational|
|Estimated Enrollment :||320 participants|
|Official Title:||Influence of Preoperative Fluid Intake on the Onset of Postoperative Acute Kidney Injury in Cardiac Surgery Patients: the HYDRATE-CSX Trial|
|Estimated Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||January 15, 2020|
|Estimated Study Completion Date :||March 15, 2020|
- Acute kidney injury [ Time Frame: 30 days ]Acute kidney injury
- Renal replacement therapy [ Time Frame: 7 days postoperative ]Renal replacement therapy
- Kidney-failure-free days [ Time Frame: 7 days postoperative ]defined as the number of days in which a patient had no acute kidney injury and no need for RRT
- Major Adverse Kidney Events [ Time Frame: 30 days ]death, dialysis or persistent renal dysfunction
- Fluid intake since hospital admission until surgery (ml/h) [ Time Frame: 30 days ]Fluid intake since hospital admission until surgery (ml/h)
- Calorie intake since hospital admission (kcal/d) [ Time Frame: 30 days ]Calorie intake since hospital admission (kcal/d)
- Preoperative abstinence of fluids (minutes) [ Time Frame: 30 days ]Preoperative abstinence of fluids (minutes)
- Preoperative abstinence of food (minutes) [ Time Frame: 30 days ]Preoperative abstinence of food (minutes)
- ICU length of stay (hours) [ Time Frame: 30 days ]ICU length of stay (hours)
- Hospital length of stay since surgery (days) [ Time Frame: 30 days ]Hospital length of stay since surgery (days)
- Mortality until hospital discharge/ 30 days [ Time Frame: up to 30 days ]Mortality until hospital discharge/ 30 days
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938181
|Contact: Julia Krieger||+49 241 email@example.com|
|Principal Investigator:||Julia Ney, Dr. med.||RWTH Aachen University|