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UnknownNCT03938181

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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
320 (estimated)
Sponsor
RWTH Aachen University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2019-04-23
Primary completion
2020-01-15
Completion
2020-03-15
First posted
2019-05-06
Last updated
2019-09-11

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03938181. Inclusion in this directory is not an endorsement.