Follow-up of patients from the study "Analysis of hemolysis frequency and dynamics in coronary bypass operations with and without Heart-lung machine"
Organizational Data
- DRKS-ID:
- DRKS00025843
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2021-07-14
- Last update in DRKS:
- 2021-07-14
- Registration type:
- Prospective
Acronym/abbreviation of the study
Hemolysis study
URL of the study
No Entry
Brief summary in lay language
In cardiac surgery, blood can be observed in the urine in a non-specific and occasionally perioperative manner. This blood in the urine is the result of destruction of blood cells. This can be a side effect when using the heart-lung machine. Possible triggers are e.g. mechanical damage caused by roller pumps, shear stress of the blood cells. A comparative study at the Surgical Clinic Munich South (Ethics Proposal No: 18-633 of 29.10.2018) answered the question of whether laboratory chemical values are measurable with regard to blood in the urine, in cardiac surgery generally increased or whether it is explicitly a side effect of the heart-lung machine. Laboratory values of patients with elective coronary bypass operations with and without a heart-lung machine were compared.The results of the study show significant differences in laboratory values to the detriment of the group of patients who were operated on with the heart-lung machine. A dysfunction of the kidney is a dreaded long-term complication. In order to be able to assess potential kidney damage with regard to the heart surgery patient clientele of the study, patients will be interviewed in this follow-up study.
Brief summary in scientific language
In cardiac surgery, macrohematuria can be observed non-specifically and occasionally perioperatively. Macrohematuria is the result of intravascular hemolysis as a side effect of the heart-lung machine. Possible triggers of hemolysis are mechanical damage caused by roller pumps, shear stress of the blood cells or the reduced oncotic pressure due to the dilution of the plasma. A monocentric, prospective comparative analysis at the Surgical Clinic Munich South (Ethics Proposal No: 18-633 of 29.10.2018) answered the question of whether laboratory chemical hemolysis parameters can be measured in cardiac surgery in general or whether it is explicitly a side effect of extracorporeal circulation. Hemolysis parameters of patients with elective coronary bypass surgery with and without a heart-lung machine were compared. The results of the hemolysis study show significant differences in laboratory chemical hemolysis parameters (free hemoglobin, haptoglobin and lactate dehydrogenase) to the detriment of the patient group operated with the heart-lung machine. Dysfunction of the renal tubules is a dreaded complication of intravascular hemolysis. In order to be able to assess potential nephrological consequential damage with regard to the cardiac surgical patient clientele of the hemolysis study, patients will be interviewed in this follow-up study.
Health condition or problem studied
- ICD10:
- D59.6 - Haemoglobinuria due to haemolysis from other external causes
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- In >20 patients (Group A) were operated without heart lung machine.
- Arm 2:
- In >20 patients (Group B) the heart lung machine was used.
Endpoints
- Primary outcome:
- The primary goal of this "hemolysis study" is to check the kidney function of patients after coronary bypass surgery with and without heart-lung machine (HLM) on the basis of special postoperative laboratory parameters (especially haptoglobilin, free Hb, but also creatinine, urea, GFR). Central goal: Is kidney function less severely impaired after bypass surgery without HLM?
- Secondary outcome:
- Hb, leukocytes, hematocrit, platelets, K, Na, Quick, PTT, bilirubin, GOT, GPT, gamma-GT Questionnaire with assessment of quality of life (Visual analogical scale 1-10), recording of complications (morbidity, including further operations, cardiac catheterization procedures, pumping power of the heart), mortality
Study Design
- Purpose:
- Basic research/physiological study
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Artemed Klinikum München Süd München
Recruitment period and number of participants
- Planned study start date:
- 2021-08-01
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 40
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Coronary bypass surgery, minimum age 18 years, positive patient consent
Exclusion Criteria
Emergency surgery, no consent, incapacitated, additional surgery (combination procedure), neurological deficit, dialysis preoperative, severe renal impairment
Addresses
Primary Sponsor
- Address:
- HerzchirurgieArtemed Klinikum München südDr. Helmut MairAm Isarkanal 3081379 MünchenGermany
- Telephone:
- +49 89 724400
- Fax:
- +49 89 72440355
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- HerzchirurgieArtemed Klinikum München SüdDr. Helmut MairAm Isarkanal 3081379 MünchenGermany
- Telephone:
- +49 89 724400
- Fax:
- +49 89 72440355
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- HerzchirurgieArtemed Klinikum München SüdDr. Helmut MairAm Isarkanal 3081379 MünchenGermany
- Telephone:
- +49 89 724400
- Fax:
- +49 89 72440355
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- HerzchirurgieArtemed Klinikum München SüdDr. Helmut MairAm Isarkanal 3081379 MünchenGermany
- Telephone:
- +49 89 724400
- Fax:
- +49 89 72440355
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- HerzchirurgieArtemed Klinikum München SüdAm Isarkanal 3081379 MünchenGermany
- Telephone:
- +49 89 724400
- Fax:
- +49 89 72440355
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Med. Fakultät der LMUPettenkoferstraße 880336 MünchenGermany
- Telephone:
- +49-89-440055191
- Fax:
- +49-89-440055192
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-02-17
- Ethics committee number:
- 20-143
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-02-02
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry