Here is the design of a clinical trial:

Official Title: Biomarker-guided Implementation of the Cardiovascular (CV) Surgery AKI Bundle to Reduce the Occurrence of AKI After Cardiac Surgery- Prevention of AKI

Included conditions:
- Acute Kidney Injury (Nontraumatic)

Study Armgroups:
- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Implementation of the cardiovascular surgery AKI bundle\n\n1. discontinuation of all nephrotoxic agents when possible\n2. optimization of volume status and hemodynamic parameters\n3. close monitoring of serum creatinine, fluid balance and urinary output\n4. avoidance of hyperglycemia\n5. considerations of alternatives to radiocontrast agents\n6. discontinuation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in the perioperative period\n7. avoidance of HES, gelatin, and chlorid-rich solutions', 'interventionNames': ['Other: Intervention']}
- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'The patients will receive standard of care (according to each center)'}

Interventions:
- {'type': 'OTHER', 'name': 'Intervention', 'description': 'Implementation of the cardiovascular AKI bundle (see arm description)', 'armGroupLabels': ['Intervention group']}

Primary Outcomes:
- {'measure': 'Compliance rate', 'description': 'proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time', 'timeFrame': '48 hours after start of intervention'}

Please estimate the sample size based on the assumption: 
The primary analysis will estimate the compliance rate with a two-sided 95% CI. The CI is calculated using the Clopper-Pearson method, and the precision of the compliance rate estimation is ±6%.
Sample size
        For the survey, no power analysis is required. The number of patients is based on surgical volumes in the two consecutive days prior to the interventional trial and is expected to be about n=100.
        In the interventional trial, 1000 patients will be assessed for eligibility, and 280 patients will be enrolled into the trial and randomised (based on our previous findings). This sample size is determined as follows:
        Patients will be randomised in a 1:1 ratio to one of the two treatment arms (intervention vs control). Randomisation serves to estimate the incidence of AKI as a secondary outcome to generate preinformation in preparation for an upcoming confirmatory trial.
        The primary endpoint of the interventional trial is the compliance rate, that is, the proportion of patients treated according to the trial protocol (intervention group: CV surgery AKI bundle fulfilled at all time; control group: documented standard of care according to current clinical practice). In order to estimate the compliance rate, the two treatment groups will be pooled together. In the primary analysis, the compliance rate across all study patients will be estimated along with a two-sided 95% CI.
        As the compliance rate cannot be quantified in advance, we pursue a worst-case approach and assume a compliance rate of 50%. In this case, the CI has maximal width. Based on this assumption, with a sample size of n=280 patients, the calculated 95% CI according to Clopper-Pearson (Fleiss 2003) ranges from 44% to 56%. Therefore, in case of any observed compliance rate apart from the worst-case scenario, the 95% CI is never wider than 56%â44%=12%. This corresponds to an estimation of the compliance rate with a precision of Â±6%.