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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Thoracic Surgery Acute Kidney Injury Critical Care

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.


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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. Acute kidney injury [ Time Frame: 30 days ]
    Acute kidney injury

  2. Renal replacement therapy [ Time Frame: 7 days postoperative ]
    Renal replacement therapy

  3. 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


Secondary Outcome Measures :
  1. Major Adverse Kidney Events [ Time Frame: 30 days ]
    death, dialysis or persistent renal dysfunction

  2. Fluid intake since hospital admission until surgery (ml/h) [ Time Frame: 30 days ]
    Fluid intake since hospital admission until surgery (ml/h)

  3. Calorie intake since hospital admission (kcal/d) [ Time Frame: 30 days ]
    Calorie intake since hospital admission (kcal/d)

  4. Preoperative abstinence of fluids (minutes) [ Time Frame: 30 days ]
    Preoperative abstinence of fluids (minutes)

  5. Preoperative abstinence of food (minutes) [ Time Frame: 30 days ]
    Preoperative abstinence of food (minutes)

  6. ICU length of stay (hours) [ Time Frame: 30 days ]
    ICU length of stay (hours)

  7. Hospital length of stay since surgery (days) [ Time Frame: 30 days ]
    Hospital length of stay since surgery (days)

  8. Mortality until hospital discharge/ 30 days [ Time Frame: up to 30 days ]
    Mortality until hospital discharge/ 30 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing elective cardiac surgery at the University Hospital RWTH Aachen
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938181


Contacts
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Contact: Julia Krieger +49 241 88726 jukrieger@ukaachen.de

Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Julia Ney, Dr. med. RWTH Aachen University

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03938181     History of Changes
Other Study ID Numbers: 3CARE_BOÄ_18-004_Hydrate-CSX
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RWTH Aachen University:
cardiac surgery patients
acute renal failure
intensive care

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases