Thoracic SurgeryHYDRATE-CSXNCT03938181
Influence of Preoperative Fluid Intake on the Onset of Postoperative Acute Kidney Injury
An observational study of Thoracic Surgery and Acute Kidney Injury, run by RWTH Aachen University at 1 site in Germany.
Trial summary
To investigate the influence of preoperative fluid and food intake in cardiac surgery patients on the development of postoperative AKI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Acute Kidney Injury, Critical Care
- How many people
- 320 participants
- Where
- 1 siteGermany
- Study dates
- 23 Apr 2019to 15 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective cardiac surgery at the University Hospital RWTH Aachen
Who may be able to join
- Adult patients (>18 years of age) scheduled to undergo elective cardiac surgery with the use of cardiopulmonary bypass (CPB) and cardioplegic arrest
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
Julia Krieger, +4924180 ext. 88726, jukrieger@ukaachen.de
About this study
Official title: Influence of Preoperative Fluid Intake on the Onset of Postoperative Acute Kidney Injury in Cardiac Surgery Patients: the HYDRATE-CSX Trial
To investigate the influence of preoperative fluid and food intake in cardiac surgery patients on the development of postoperative AKI.
Read the 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
- Thoracic Surgery, Acute Kidney Injury, Critical Care
- Keywords
- cardiac surgery patients, acute renal failure, intensive care
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
Acute kidney injury
Measured: 30 days
Renal replacement therapy
Renal replacement therapy
Measured: 7 days postoperative
Kidney-failure-free days
defined as the number of days in which a patient had no acute kidney injury and no need for RRT
Measured: 7 days postoperative
Secondary outcomes (8)
Major Adverse Kidney Events
death, dialysis or persistent renal dysfunction
Measured: 30 days
Fluid intake since hospital admission until surgery (ml/h)
Fluid intake since hospital admission until surgery (ml/h)
Measured: 30 days
Calorie intake since hospital admission (kcal/d)
Calorie intake since hospital admission (kcal/d)
Measured: 30 days
Preoperative abstinence of fluids (minutes)
Preoperative abstinence of fluids (minutes)
Measured: 30 days
Preoperative abstinence of food (minutes)
Preoperative abstinence of food (minutes)
Measured: 30 days
ICU length of stay (hours)
ICU length of stay (hours)
Measured: 30 days
Hospital length of stay since surgery (days)
Hospital length of stay since surgery (days)
Measured: 30 days
Mortality until hospital discharge/ 30 days
Mortality until hospital discharge/ 30 days
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start23 Apr 2019
- Primary completion15 Jan 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Ney, Dr. med., Principal investigator, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938181
- Sponsor's protocol ID
- 3CARE_BOÄ_18-004_Hydrate-CSX
- Acronym
- HYDRATE-CSX
- Status last verified
- Sep 2019
- First submitted
- 2 May 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Preoperative Fluid Intake on the Onset of Postoperative Acute Kidney Injury in Cardiac Surgery Patients: the HYDRATE-CSX Trial
- ClinicalTrials.gov ID
- NCT03938181
- Acronym / sponsor ID
- HYDRATE-CSX / 3CARE_BOÄ_18-004_Hydrate-CSX
- Conditions
- Thoracic Surgery, Acute Kidney Injury, Critical Care
- Keywords
- cardiac surgery patients, acute renal failure, intensive care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 15 Jan 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective cardiac surgery at the University Hospital RWTH Aachen
Key inclusion criteria (1 listed)
- Adult patients (>18 years of age) scheduled to undergo elective cardiac surgery with the use of cardiopulmonary bypass (CPB) and cardioplegic arrest
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Major Adverse Kidney Events
Time frame: 30 days
Fluid intake since hospital admission until surgery (ml/h)
Time frame: 30 days
Calorie intake since hospital admission (kcal/d)
Time frame: 30 days
Preoperative abstinence of fluids (minutes)
Time frame: 30 days
Preoperative abstinence of food (minutes)
Time frame: 30 days
ICU length of stay (hours)
Time frame: 30 days
Hospital length of stay since surgery (days)
Time frame: 30 days
Mortality until hospital discharge/ 30 days
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Ney, Dr. med. principal investigator
RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery and Acute Kidney Injury, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Krieger (+49 241 88726, jukrieger@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.