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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03938181
Acronym
HYDRATE-CSX
Enrollment
320
Registered
2019-05-06
Start date
2019-04-23
Completion date
2020-03-15
Last updated
2019-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Critical Care, Thoracic Surgery

Keywords

cardiac surgery patients, acute renal failure, intensive care

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.

Interventions

None listed

Sponsors

RWTH Aachen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acute kidney injury30 daysAcute kidney injury
Renal replacement therapy7 days postoperativeRenal replacement therapy
Kidney-failure-free days7 days postoperativedefined as the number of days in which a patient had no acute kidney injury and no need for RRT

Secondary

MeasureTime frameDescription
Preoperative abstinence of fluids (minutes)30 daysPreoperative abstinence of fluids (minutes)
Preoperative abstinence of food (minutes)30 daysPreoperative abstinence of food (minutes)
Major Adverse Kidney Events30 daysdeath, dialysis or persistent renal dysfunction
Hospital length of stay since surgery (days)30 daysHospital length of stay since surgery (days)
Mortality until hospital discharge/ 30 daysup to 30 daysMortality until hospital discharge/ 30 days
ICU length of stay (hours)30 daysICU length of stay (hours)
Fluid intake since hospital admission until surgery (ml/h)30 daysFluid intake since hospital admission until surgery (ml/h)
Calorie intake since hospital admission (kcal/d)30 daysCalorie intake since hospital admission (kcal/d)

Countries

Germany

Contacts

Primary ContactJulia Krieger
jukrieger@ukaachen.de+49 241 88726

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026